louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00145834: Early Breastfeeding Cessation - is It Possible to Prevent?
Official title: A Randomised Community Based Experimental Trial in the Health Visitor's Practice Field
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breastfeeding
Practice
Maternal Behaviour
Self-Efficacy
Keywords: psychosocial factors
breastfeeding
postnatal intervention
health visitor
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
name: Sygekassernes Helsefond
name: Ringkjobing Amt
name: Ribe Amt
First posted: 2005-09-05
Enrollment: 1456
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate if a postnatal public health breastfeeding intervention relying on the importance of the psychosocial factors can prolong the period with exclusive breastfeeding duration among mothers who want to breastfeed.

Detailed description: Breastfeeding is a complex learned behaviour and not a capability which comes naturally with motherhood. Different types of professional recommendations have been used to support the new mother in this process.

Randomised studies have shown that postnatal support can influence the breastfeeding duration positively. Various studies has offered different kinds of interventions with home visits and/or telephone calls as the generally used approach, but the proper follow-up on the breastfeeding support in the postnatal period after the mother leaves the hospital is not yet clear.

Eligibility criteria: Inclusion Criteria:

* Danish mother, single child, gestational age of not less than 37 full weeks

Exclusion Criteria:

* Mothers with an ethic background other than Danish, preterm delivery,twin birth

Primary outcomes:
measure: Breastfeeding duration
Secondary outcomes:
measure: Satisfaction with the breastfeeding period
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Institute of Publich Health, Department of Nursing Science, University of Aarhus
Study officials:
affiliation: Department of Nursing Science, University of Aarhus
name: Ingegerd Harder, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01877434: Reversed TESS Shoulder Artroplasty
Official title: The TESS Reverse Shoulder Arthroplasty: Effect of Arm Lengthening and Early Scapular Notching at Three Years Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Humerus Fracture
Degenerative Shoulder Pain
Degenerative Supraspinatus Rupture
Keywords: Reversed shoulder arthroplasty
Treatment
TESS
Lead sponsor: Sundsvall Hospital
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergone reversed shoulder arthroplasty at Sundsvall hospital, Sweden between 2007-2012

Brief summary: Reverse total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder diseases with improved functional outcome. This study has evaluated patients operated with reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported outcome, clinical and radiological examination, complication and reoperations. The radiologic phenomenom and clinical impact of scapular notching (SN) and arm length difference has been evaluated.


Eligibility criteria: Inclusion Criteria:

* Operated with a reversed TESS total shoulder arthroplasty at Sundsvall hospital.

Exclusion Criteria:

* Do not give informed consent
* Do not attend follow-up

Primary outcomes:
measure: Patient reported outcome measurement Quick-DASH
timeFrame: 2007-2013
Secondary outcomes:
measure: Range of movement
timeFrame: 2007-2013
measure: Quality of life EQ5-D
timeFrame: 2007-2013
Other outcomes:
measure: Arm lenght difference
timeFrame: 2007-2013
Locations:
city: Sundsvall
country: Sweden
facility: Institution of surgical and operative sciences, Umeå University
state: Västernorrland län
Study officials:
References:
Clinical trial NCT00775034: Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair
Official title: Drainage Versus Sealant in Double Blinded Monocentric Open Incisional Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Incisional Hernia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2008-10-17
Enrollment: 57
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: Mesh repair for open incisional hernia repair with fibrin sealant or with drainage


Eligibility criteria: Inclusion Criteria:

* All patients with a large incisional hernia \>5cm diameter that needs elective repair with mesh augmentation

Exclusion Criteria:

* no written informed consent
* 'hostile' abdomen
* emergency surgery (incarcerated hernia)
* parastomal hernia
* incisional hernia outside the midline
* recurrent incisional hernia

Primary outcomes:
measure: Hospital stay
timeFrame: At time of discharge
Secondary outcomes:
measure: Postoperative drainage volume
timeFrame: Day 0,1, 2, 3 ? and at day of removal
measure: Perioperative morbidity rate
timeFrame: At time of discharge
measure: Pain measured using VAS
timeFrame: Daily till discharge and after 3 weeks post-surgery
measure: Quality of life by SF-36 questionnaire
timeFrame: Preoperatively, at time of discharge, 2 weeks after discharge, 6 weeks after discharge and 1 year post surgery
measure: Recurrence
timeFrame: At one year
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Leuven
country: Belgium
facility: UZ gasthuisberg Leuven
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01057134: Ultrasound Device for Hair Removal
Official title: Cutera UHAIR for Hair Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Hair Removal
Keywords: Hair Reduction Arm Leg
Unwanted hair
Lead sponsor: Cutera Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the Cutera UHAIR ultrasound device for hair removal.

Detailed description: The purpose of this study is to evaluate the Cutera UHAIR device for safety and efficacy for removal and long term reduction of unwanted hair on subjects with Fitzpatrick skin types I-IV and dark (black or brown), red, and blonde colored hair.

At investigator's discretion, each subject will receive treatments and will be scheduled for follow-up visits after the final treatment. The treated area(s) will be photographed at each visit for analysis.

Eligibility criteria: Inclusion Criteria:

* Male or female at least 18 years of age
* Fitxpatrick skin type I-IV
* Area with unwanted hair
* Subject must be able to read, understand and sign the consent form
* Subject must adhere to the follow-up schedule and study instruction

Exclusion Criteria:

* Simultaneous participation in any other clinical study
* Inability or unwillingness to follow the treatment schedule
* Inability or unwillingness to sign the informed consent
* Infection in the target area
* Any disease or condition that could impair wound healing
* History of keloid formation
* History of malignant tumors in the target area
* Skin abnormalities in the target area, e.g. cuts, scrapes, wounds, scars, large moles
* History of hair removal in target area (light based or electrolysis)
* Pregnant or lactating

Primary outcomes:
measure: Reduction in Hair Count in the Treated Area
timeFrame: baseline and 3 months post final treatment (up to 28 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02236234: Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil
Official title: Immune Response to HPV Vaccine Among HIV-1-infected Subjects in Brazil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection
Keywords: HIV
HPV
Clinical trial
outcome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 30
Sex: MALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Besides the specific response to vaccine antigens, the investigators will analyze the anti-HPV immune response in HIV-1-infected men in different strata of immune deficiency. The hypothesis will be tested by stratification by T CD4 + lymphocytes in an attempt to assess the range of the count with the highest possibility of vaccine response. Thus, knowledge of vaccine response in HIV-infected patients, indicate which patients would have greater potential for vaccine response in vivo.

Detailed description: The study will be divided into three groups. Patients with HIV-1 infection will be subdivided into groups according to T CD4 + lymphocytes at the time of vaccination: Over 500 CD4 T cells count and bellow 500 CD4 T cells count. A healthy control group will be also studied.

Eligibility criteria: Inclusion Criteria: HIV

* Men with age between 35 and 45 years of age.

Exclusion Criteria:

* Current or previous infection with human papillomavirus (HPV)

Primary outcomes:
measure: Presence of Anti-HPV antibody titers
timeFrame: 0, 30 and 180 days of vaccination anti-HPV
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Tropical Medicine of Sao Paulo
state: SP
Study officials:
affiliation: USP
name: jorge casseb, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04911634: Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors
Official title: Laparoscopic Ultrasound Guided Minimal Invasive Excision of Intra-/Retroperitoneal Tumors in Patients Scheduled for Laparotomy: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laparoscopic Ultrasound
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients were discussed at the Upper or Lower GI Multidisciplinary Team conferences MDT in order to make sure that only patients where explorative laparotomy was considered the next and only possible clinical step, were referred for the minimal invasive procedure.

Brief summary: Patients included in the study went through standard preoperative preparation and were informed about potential conversion to open surgery. The procedure started with LUS performed according to the department's standard guidelines (one twelve mm trocar in the midline and one 12 mm trocar in the left upper quadrant) followed by a stepwise scanning of relevant structures (e.g. liver, pancreas, retroperitoneum) with dedicated laparoscopic ultrasound equipment (BK Medical, Herlev, Denmark). If the suspected lesion(s) was detected by LUS in the relevant area (according to preoperative imaging), laparoscopic resection was attempted, and if successful the specimen was removed in an eEndo-bBag (Kebomed, Denmark) through one of the trocars. A second LUS was performed to ensure that no tumor was left behind ("loss-of-lesion(s)").

If any problem occurred during the laparoscopic procedure, the operation was converted to an open procedure. Prophylactic antibiotics were not given routinely but were administered during surgery at the surgeons' discretion.

The intra- and postoperative course and final clinical outcome including pathology reports were retrieved from the patient's electronical records. This included a postoperative follow up of at least 12 months to investigate potential incomplete resection. Postoperative complications were graded according to Dindo-Clavien (17). The pathology reports were retrieved from the Danish Pathology Registry.


Eligibility criteria: Inclusion Criteria:

Patients with intra- and retroperitoneal tumor(s) (IRT) detected by imaging (US/CTMR/PET or EUS) and a clinical indication for explorative laparotomy

Exclusion Criteria:

Patients with contraindications for laparoscopy, such as severe adherences were excluded

Primary outcomes:
measure: Tumor localization
timeFrame: 12 months
measure: LUS guided resection
timeFrame: 12 months
Secondary outcomes:
measure: Complications
timeFrame: 12 months
measure: Final diagnosis
timeFrame: 12 months
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT04554134: The Hybrid Combination of CCTA and SPECT and CAG for Evaluation Prognosis of CAD: an Observational Follow-up Study
Official title: The First Affiliated Hospital of Nanjing Medical University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: SPECT
CCTA
CAG
Hybrid
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Huai'an First People's Hospital
name: Changzhou No.2 People's Hospital
First posted: 2020-09-18
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were suspected coronary artery disease and underwent CCTA, SPECT and CAG within 3 months from 2005 to 2015.

Brief summary: A total of 550 patients with stable angina (40-70% stenosis) tested by coronary CT angiography (CCTA) and single photon emission computed tomography (SPECT) and coronary angiography (CAG) within 3 months were retrospectively recruited from 2005 to 2015 and follow up to 5 years. A new hybrid software was used to analysis the image data.


Eligibility criteria: Inclusion Criteria:

1. Age: 18-70
2. Gender: All
3. coronary artery disease patients (CAD)
4. underwent CCTA, SPECT and coronary angiography (CAG) together within 3 months
5. Time: 2005-2015

Exclusion Criteria:

1. dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), congenital heart disease (CHD), atrial fibrillation (AF), ventricular tachycardia (VT)
2. Prior coronary revascularization;
3. permanent pacemaker or internal defibrillator
4. prosthetic heart valve
5. coronary image lose
6. coronary artery severe calcification
7. motion artifacts and poor CCTA image quality

Primary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 5 YEARS
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital Hospital of Nanjing Medical University
name: Yi Chai, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05817734: Human Phenotype Project Study Protocol
Official title: Longitudinal Collection of Observational Clinical and Lifestyle Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Disease
Lead sponsor: Weizmann Institute of Science
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General volunteering population who can freely register for the study.

Brief summary: This is a prospective study aimed at recruiting 30,000 individuals, aged 40-70 years old, and following them longitudinally for 25 years with repeated measurements. The basic follow-up frame will include a visit to the Clinical Test Center (CTC) every two years and a phone interview every other year (on uneven years). Sample collection and biobanking will be performed every two years and online questionnaires will be filled out on an annual basis.

The primary goals are to study the variation observed across different individuals in disease susceptibility, clinical phenotypes, and therapeutic responses. The study aims at studying the complex interplay and relative contribution of different omics, physiological characteristics and lifestyle on disease pathogenesis and progression and to evaluate how these effects are mediated.


Eligibility criteria: Inclusion Criteria:

* Ages 18+, males and females.

Exclusion Criteria:

* Pregnancy.
* Mentally disabled or in general legally non-competent.
* Prisoner or soldier. Soldiers: mandatory service only
* Active cancer
* Fertility Treatments (current)
* Hepatitis ( B, C), chronic or acute
* HIV
* Liver cirrhosis
* Dialysis
* Unstable medical conditions

Primary outcomes:
measure: Adult disease
timeFrame: 25 years
Secondary outcomes:
Other outcomes:
Locations:
city: Reẖovot
country: Israel
facility: Weizmann institute of science
Study officials:
References:
Clinical trial NCT04789434: PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT
Official title: PD-1 Inhibitor Tislelizumab Maintenance Therapy in Newly Diagnosed DLBCL Patients After ASCT: A Multicenter, Randomized Controlled Clinical Study on Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lymphoma, Large B-Cell, Diffuse
Transplantation
Chemotherapy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT).

Detailed description: This is a multicenter, randomized controlled, prospective clinical trial. The objective is to investigate the efficacy and safety of Tislelizumab maintenance therapy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients after autologous hematopoietic stem cell transplantation (ASCT). 94 patients were randomly divided into two groups according to the ratio of 1:1. The whole trial included screening period (day-28 to day-1), treatment period (Tislelizumab, 200mg every 8 weeks, 12 times) and follow-up period (2 years after the enrollment).

Eligibility criteria: Inclusion Criteria:

1. Male and female, aged 18-65;
2. newly-diagnosed high risk (aaipi 2-3 and aaipi 1 with large mass) DLBCL patients after autologous stem cell transplantation;
3. Laboratory tests (blood tests, liver and renal function) meet the following requirements:

   1. Blood tests: white blood cell count ≥ 3.0 × 109 / L, absolute neutrophil count ≥ 1.5 × 109 / L, hemoglobin ≥ 90g / L, platelet ≥ 75 × 109 / L
   2. Liver function: transaminase ≤ 2.5 × upper limit of normal value, bilirubin ≤ 1.5 × upper limit of normal value;
   3. Renal function: serum creatinine 44-133 mmol / L;
4. The score of ECOG was 0-2;
5. The subject or his legal representative must provide written informed consent before the special examination or procedure of the study.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Severe complications or infection;
3. Lymphoma involving central nervous system;
4. Participate in other clinical trials at the same time;
5. According to the judgment of the researcher, the patients who are not suitable for this study were selected.

Primary outcomes:
measure: progression-free survival
timeFrame: 2-years after enrollment
Secondary outcomes:
measure: complete remission rate
timeFrame: 2-years after enrollment
measure: overall survival
timeFrame: 2-years after enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06479434: Serum Biomarker Levels Improvement in Poly Cystic Ovarian Syndrome: Impact of Metformin Compared to Healthy Controls
Official title: Association of Serum Biomarkers in Polycystic Ovarian Syndrome (PCOS) Females With and Without Metformin Versus Healthy Controls
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: University of Karachi
First posted: 2024-06-28
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this interventional study is to assess the effect of drug metformin in improving the fertility hormones and reducing the inflammatory hormones in polycystic ovarian syndrome (PCOS) patients. We wish to answer the question whether metformin is necessary to improve PCOS symptoms versus simple lifestyle modification.

Participants once diagnosed with PCOS will be given metformin to be sued for 8 weeks. They will be asked to provide blood samples on day 0 and after 8 weeks of metformin use. The blood sample will be used to measure the hormonal and inflammatory profile. In addition, they will be required to compete a questionnaire regarding symptoms such as decrease in facial hair growth, improvement in menstrual cycle etc.


Eligibility criteria: Inclusion Criteria:

a) Patients Falling into PCOS as per Rotterdam criteria

Exclusion Criteria:

1. Systemic diseases like atherosclerosis,
2. Diabetes mellitus
3. Hypertension
4. congenital adrenal hyperplasia, androgen secreting tumors

Primary outcomes:
measure: Change in hormonal profile and menstural Cycle after Metformin use
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in symptoms associated with PCO after intervention
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: DBBS
state: Sind
Study officials:
affiliation: Aga Khan University
name: Sadia Fatima, PhD
role: STUDY_DIRECTOR
References: