louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06983626: Management of Non Obstructive Azoospermia in Men
Official title: Predictive Factors of Successful Micro-dissection Testicular Sperm Extraction For Patients With Non Obstructive Azoospermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Azoospermia, Nonobstructive
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 300
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: this study predicts the factors of successful micro testicular sperm extraction in azoospermia patients in male infertility

Detailed description: primary outcomes: these factors were the age, testicular size, hormonal, evidence of varicocles and the out come of Micro_TESE secondary outcomes: make good decision for Micro-TESE with low economic laboratory and radiology requirement As every failed microTESE-ICSI procedure exposes the couple to an emotional, financial burden and increase the incidence of complication such as bleeding, hematoma and testicular atrophy

Eligibility criteria: Inclusion Criteria: Non obstructive Azoospermia with no genetic abnormalties as klinefelter syndrome

* redo Micro TESE

Exclusion Criteria:

* obstructive Azoospermia and bilateral congenital absent of vas

Primary outcomes:
measure: Sperm Retrieval Success Rate and identification of Predictive Factors
timeFrame: 1st 1 year
Secondary outcomes:
measure: Assess the success rates of ART procedures following sperm retrieval and complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Luxor
country: Egypt
facility: Faculty of Medicine, South Valley University
state: Qena
Study officials:
affiliation: South Valley University
name: Gamal abdelhammid alsagheer, professour of urology, professour
role: STUDY_DIRECTOR
References:
Clinical trial NCT02502526: Comparison of Centurion® Vision System With Balanced Tip and the Infiniti® Vision System With the Mini Flared Kelman (MFK) Tip During Cataract Extraction Surgery of Hard Lenses
Official title: Comparison of Cumulative Dissipated Energy (CDE) and Balanced Salt Solution (BSS) Fluid Used With the Centurion® With the 45° Degree Balanced Ultrasound (U/S) Tip vs the Centurion® With Mini Flared Kelman U/S Tip vs the Infiniti® With Mini Flared Kelman U/S Tip on Hard Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-07-20
Enrollment: 231
Sex: ALL
Minimum age (years): 21
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 demonstrate that the Centurion® Vision System (CVS) used with the 45° Balanced Tip will result in less Cumulative Dissipated Energy (CDE) than the lnfiniti® Vision System (IVS) used with the 45° Mini-Flared Kelman (MFK) tip during cataract extraction surgery via phacoemulsification of cataract grades NII- NIV \[Lens opacities classification system II (LOCSII)\].


Eligibility criteria: Inclusion Criteria:

* Willing and able to consent for participation;
* Willing and able to attend postoperative examinations per protocol schedule;
* Cataract in at least one eye with a Nuclear Opalescence of II-IV (via LOCSII) followed by posterior chamber intraocular lens (IOL) implantation;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Planned multiple procedures, including Laser Phaco, LASIK, LRI's etc. during surgery or the course of this study;
* Severe conditions of acute or chronic diseases or illnesses that would increase the operative risk or confound the result of this investigation;
* Untreated or uncontrolled Glaucoma;
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes;
* Poorly dilating pupil or other pupil defect;
* Current or previous use of an alpha-1-selective adrenoceptor blocking agent or antagonist of alpha 1A adrenoceptor (eg, Flomax®, Hyntrin®, or Cardura®);
* Severe retinal disorders;
* Corneal disease or retinal detachment;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Cumulative Dissipated Energy (CDE)
timeFrame: Day 0 (operative day)
Secondary outcomes:
measure: Cumulative Dissipated Energy (CDE)
timeFrame: Day 0 (operative day)
measure: Balanced Salt Solution (BSS) Fluid Used
timeFrame: Day 0 (operative day)
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Alcon, A Novartis Division
role: STUDY_DIRECTOR
References:
Clinical trial NCT04829526: Firm Observational Clinical Unicenter Study on Guillain Barré Syndrome
Official title: Firm Observational Clinical Unicenter Study on Guillain Barré Syndrome (FOCUS on GBS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Guillain-Barre Syndrome (GBS)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with the suspected and with the final proven diagnosis of GBS in the years 2005-2021

Brief summary: The aim of this retrospective observational single-center cohort study is to gain a deeper understanding regarding the frequency, the clinical and electrophysiologic characteristics (e.g., the diagnostic work up), complications, treatment regimes, and their associations with specific courses of disease and outcomes in adult patients with the suspected or proven diagnosis of GBS.

Detailed description: Guillain Barré Syndrome (GBS) is a rare and life-threatening neurological emergency. The aim of this retrospective study including adult GBS patients from the last 15 years treated at the University Hospital of Basel is to assess data regarding diagnostic workup, treatment, clinical course including complications and outcomes.

Eligibility criteria: Inclusion Criteria:

* suspected diagnosis of GBS, who have been treated at the University Hospital of Basel from 01.01.2005-28.02.2021

Exclusion Criteria:

* Patients with documented refusal of the general consent.

Primary outcomes:
measure: frequency of GBS
timeFrame: one time retrospective assessment at baseline
measure: clinical characteristics of GBS
timeFrame: one time retrospective assessment at baseline
measure: electrophysiologic characteristics of GBS
timeFrame: one time retrospective assessment at baseline
measure: complications of GBS
timeFrame: one time retrospective assessment at baseline
measure: treatment regimes of GBS
timeFrame: one time retrospective assessment at baseline
measure: outcomes of GBS
timeFrame: one time retrospective assessment at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinic for Intensive Care Medicine; University Hospital Basel
Study officials:
affiliation: Clinic for Intensive Care Medicine, University Hospital Basel
name: Raoul Sutter, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04797026: Penpal Loneliness Project
Official title: Reducing Loneliness With Penpal Connections
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Loneliness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 5 care facility residents paired with a similar amount of students as a pilot. If this program is successful, we will plan to amend IRB to include larger numbers
Primary purpose: OTHER

Brief summary: The purpose of this research is to study whether sending letters helps reduce loneliness for either the facility resident or the teenager.

Detailed description: Hypothesis: Our hypothesis is that a social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitiative measures of loneliness

Aims, purpose, or objectives:

Our objective is to reduce loneliness and increase quality of life for patients residing in residential care facilities and for high school students.

Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):

In response to the Covid pandemic, to protect their residents, residential care facilities have implemented restrictions limiting visitors as well as social activities. Anecdoctally this has negative impacted the quality of life of those residents, increasing their loneliness. Previous studies have shown positive impact of intergenerational programs including penpal programs.

Eligibility criteria: Inclusion Criteria:

* Care facility residents with capacity to make decisions:
* Measured via their most recent cognitive assessment;
* Subjectively measured via nursing staff.
* High school students will be invited via recommendation of their instructors and school administrative staff:
* Parental permission will be required.

Exclusion Criteria:

* Care facility residents that have significant cognitive impairment.
* Residents who lack decision-making capacity.

Primary outcomes:
measure: Loneliness Alleviation with Letter Writing
timeFrame: 6 months; may be extended
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Susan Laabs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00015626: A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
Official title: A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insulin Resistance
Diabetes Mellitus
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-04-26
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.


Eligibility criteria: Inclusion criteria:

1. Obese patients (wt \> 95th percentile for age, for adults increased BMI \> 27) greater than 5 years of age
2. And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism
3. Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT.
4. Family history of type II diabetes.

Exclusion Criteria:

1. Critically ill patients, patients will congestive heart failure, renal or liver insufficiency
2. Inability to give consent.
3. History of poor compliance with physician's recommendations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Cornell University
state: New York
Study officials:
References:
citation: Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
Clinical trial NCT05244226: Pediatric Pain Optimization After Tonsillectomy
Official title: Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Tonsillitis
Pain, Procedural
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery.

Detailed description: This is a single center, randomized, double blind, parallel-group dose escalation investigation which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as intraoperative analgesics. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be collected for up to 30 days post-operatively.

Eligibility criteria: Inclusion Criteria:

* Children ages 3 to 17 years old
* Presenting for elective tonsillectomy +/- adenoidectomy
* Provide informed consent / assent (as appropriate)

Exclusion Criteria:

* History of liver or kidney disease
* Females with positive pregnancy test
* Severe sleep apnea (Sleep study with Apnea Hypopnea Index (AHI) \> 10)
* Consistent daily opioid use for chronic pain ( \>3 months)

Primary outcomes:
measure: Total Amount of Opioid Medications Administered
timeFrame: Up to 7 days post surgery
Secondary outcomes:
measure: Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain
timeFrame: Up to 7 days post surgery
measure: NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale
timeFrame: Up to 7 days post surgery
measure: Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale
timeFrame: Up to 7 days post surgery
measure: Doses of Prescription Opioid Used Following Hospital Discharge
timeFrame: Up to 7 days post surgery
measure: Opioid Administration in the PACU (Post-anesthesia Care Unit)
timeFrame: Up to 6 hours post surgery
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Lisa M Einhorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Einhorn LM, Hoang J, La JO, Kharasch ED. Single-dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double-blind Clinical Trial. Anesthesiology. 2024 Sep 1;141(3):463-474. doi: 10.1097/ALN.0000000000005031.
Clinical trial NCT06488326: Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteers
Official title: Effect of Mulberry Leaf Extract Capsule on Blood Glucose Control in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health, Subjective
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Mae Fah Luang University
First posted: 2024-07-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Volunteers will be divided into 4 groups which are mulberry leaf extract 6 mg capsule, mulberry leaf extract 12 mg capsule, mulberry leaf extract 18 mg capsule, and placebo capsule group. They will be tested blood glucose levels (taken from the fingertips) before starting. Then, they will take 1 capsule of the sample one time. After taking the sample for 30 minutes, they will take 50 g of sucrose in 250 ml of water in 5 minutes. Then, they will be tested blood glucose levels (taken from the fingertips) at 30, 60, 90, and 120 minutes.


Eligibility criteria: Inclusion Criteria:

* Age 18-60 years
* No diabetes mellitus
* Have blood glucose less than 126 mg/dL
* Wiling to attend the study

Exclusion Criteria:

* Take steroids, psychiatric medicine, thiazide diuretic medicine, and beta blocker medicine within 2 weeks before starting of the study
* Take dietary supplement, herbal substance, and weight-loss medicine within 2 weeks before starting of the study
* Uncontrolled diseases
* History of gastrointestinal tract surgery
* Liver and Kidney diseases
* Pregnancy and lactation

Primary outcomes:
measure: Blood glucose
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02631226: Multi-resistant Enterobacteriaceae Colonisation in Less Than 32 Weeks Pregnant Women Admitted to the Hospital.
Official title: Multi-resistant Enterobacteriaceae Colonisation in Less Than 32 Weeks Pregnant Women Admitted in the Hospital: a Multicenter Study (EME Study).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multi-resistant Enterobacteriaceae Colonisation
Pregnancy
Nosocomial Outbreaks
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 580
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Less than 32 weeks pregnant woman admitted to the hospital and her newborn if the mother is a multi-resistant enterobacteriaceae carrier.

Brief summary: The purpose of this study is to determine the prevalence and risk factors for multi-resistant enterobacteriaceae colonization in less than 32 weeks pregnant women admitted to the hospital and its transmission to the newborn, in order to avoid neonatal intensive care unit spread and nosocomial outbreaks.


Eligibility criteria: Inclusion Criteria:

* Less than 32 weeks pregnant woman
* Admitted to the hospital

Exclusion Criteria:

* Screening done after 48 hours of admission
* When delivery occurs before screening is performed

Primary outcomes:
measure: Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women
timeFrame: 18 months
Secondary outcomes:
measure: Prevalence of multi-resistant enterobacteriaceae colonisation of African or Asian pregnant women
timeFrame: 18 months
measure: Incidence of multi-resistant enterobacteriaceae colonisation of pregnant women admitted to the hospital by preterm premature rupture of membranes (PPROM)
timeFrame: 18 months
measure: Transmission rate from the colonized woman to the newborn
timeFrame: 18 months
measure: Number of multi-resisitant enterobacteriacea sepsis in the Neonatal Unit
timeFrame: 18 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital de Sabadell. Corporacio Sanitaria Parc Tauli
state: Barcelona
Study officials:
References:
Clinical trial NCT01380626: Effects of Exercise Training in Chronic Obstructive Pulmonary Disease Versus Alpha-1-Antitrypsin-deficiency-patients
Official title: Effects of Exercise Training on Quadriceps Gene Expression in COPD-patients in Comparison to Alpha-1-Antitrypsin-deficiency-patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Alpha-1-antitrypsin-deficiency
Keywords: alpha-1-antitrypsin-deficiency
COPD
exercise training
muscle biopsy
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: Grifols Therapeutics LLC
name: Alpha-1 Foundation
First posted: 2011-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation in regard to improvement of 6-minute-walking distance. The aim of this study is to investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with strength and endurance training. In addition to conventional diagnostic procedures, muscle biopsies from the M. vastus lateralis will be conducted before and after rehabilitation program followed by biochemical, histochemical and immunohistochemical analysis of the probes.


Eligibility criteria: Inclusion Criteria:

* COPD
* Alpha-1-Antitrypsine-deficiency, phenotype: ZZ
* FEV1%pred. \<50

Exclusion Criteria:

* acute exacerbation
* exacerbation in the last 4 weeks

Primary outcomes:
measure: aerobic and anaerobic enzymes
timeFrame: day 2 and 23
Secondary outcomes:
measure: maximal exercise capacity in incremental cycling test
timeFrame: day 2 and 23
measure: 6-minute-walking distance
timeFrame: day 3 and 24
Other outcomes:
Locations:
city: Berchtesgaden
country: Germany
facility: Klinikum Berchtesgadener Land
Study officials:
affiliation: Klinikum Berchtesgadener Land, Schön Klinik
name: Klaus Kenn, Dr. med.
role: STUDY_CHAIR
References:
Clinical trial NCT05175326: Study on the Consistency Evaluation of Organoids Used in the Clinical Treatment of Ovarian Cancer With Anti-tumor Drugs
Official title: Study on the Consistency Evaluation of Organoids Used in the Clinical Treatment of Ovarian Cancer With Anti-tumor Drugs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Organoid
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with histologically confirmed ovarian cancer from Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Brief summary: This is a single-center, observational clinical study that plans to recruit 64 ovarian cancer patients within one year. The purpose of this study is to evaluate the consistency and accuracy of the organoid model derived from patients with ovarian cancer and the patient's clinical medication, so as to predict the clinical efficacy of anti-cancer drugs


Eligibility criteria: Inclusion Criteria:

- Patients with ovarian cancer who are diagnosed as ovarian cancer by tissue and/or cytology and need neoadjuvant, adjuvant or standard treatment Age 18-75 years old (including 18 years old and 75 years old) It is clear that there are measurable lesions (according to RECIST1.1)

Exclusion Criteria:

- Patients with concurrent radiotherapy and chemotherapy, less than half a year of radiotherapy, or patients undergoing radiotherapy during the study period During the study period, patients need other tumor treatment methods such as surgery, intervention, radiofrequency ablation, etc.

Immune deficiency or severe bone marrow suppression The patient has severe liver and kidney disease, cardiovascular disease, blood disease, etc.

Illegal use of drugs or chronic alcohol abuse or total daily alcohol intake\> 50 g/d Lack of autonomy, unable to walk, or unable to participate in the 6-month follow-up

Primary outcomes:
measure: Prediction of the response to treatment by the patient-derived organoids
timeFrame: 2021-2022
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: The Sun Yat-sen Memorial Hospital of Sun Yat-Sen University
name: Rao Qunxian
role: STUDY_DIRECTOR
References: