louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00433199: Testosterone Treatment for Hypogonadal Men
Official title: A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism
Keywords: Hypogonadism
Testosterone Deficiency
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-02-09
Enrollment: 274
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men


Eligibility criteria: Inclusion Criteria:

* Low T males 18 - 80 years of age

Exclusion Criteria:

* Normal T levels
* Elevated Prostatic Specific Antigen (PSA)

Primary outcomes:
measure: Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112
timeFrame: Day 112
Secondary outcomes:
measure: Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14
timeFrame: Day 14
measure: Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56
timeFrame: Day 56
measure: Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182
timeFrame: Day 182
measure: Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.
timeFrame: Day 266
measure: Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.
timeFrame: Day 364
Other outcomes:
Locations:
Study officials:
affiliation: Abbott Products
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
citation: Kaufman JM, Miller MG, Fitzpatrick S, McWhirter C, Brennan JJ. One-year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: results of a 182-day open-label extension of a 6-month double-blind study. J Sex Med. 2012 Apr;9(4):1149-61. doi: 10.1111/j.1743-6109.2011.02630.x. Epub 2012 Feb 9.
Clinical trial NCT05552599: Body Temperature Changes and Early Postoperatıve Pressure Sore
Official title: The Effect of Body Temperature Changes Durıng Total Knee Arthroplasty Surgery on The Formatıon of Early Postoperatıve Pressure Sore
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Sore
Orthopedic Disorder
Hypothermia
Nursing Caries
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to determine effect of body temperature changes during total knee arthroplasty surgery on early postoperative pressure sore formation.

Detailed description: BACKGROUND: Intraoperative hypothermia for a prolonged period increases the risk of hospital-acquired pressure sores.

PURPOSE: This study aims to determine effect of body temperature changes during total knee arthroplasty surgery on early postoperative pressure sore formation.

METHODS: This experimental study was performed with experimental-control group (N=122) patients. Data were collected with "Personal Information Form", "Body and Ambient Temperature Record Form", "Braden Risk Assessment Scale". Experimental group participants were covered with a wool blanket, and control group was given standard care.

Eligibility criteria: Inclusion Criteria:

* Aged 20-85 years
* Hospitalized for at least four days and accepted to participate were included in the study.

Exclusion Criteria:

* Under the age of 20 - over 85,
* Pregnant and having comorbid diseases,
* Spinal cord injuries,
* Skin problems in areas where there is a risk of pressure loss,
* Undergoing hemodialysis,
* Having creatinine and serum albumin levels higher than 3 mg/dl,
* Having immobility, incontinence, anemic, having malignant tumor(s),
* BMI \<19 or BMI \>40,
* Hemoglobin level below 10 g/dl,
* Infection,
* American Society of Anesthesiology (ASA) score of 3 or more,
* Experiencing friction, tearing and shearing,
* Undergoing more than one surgical intervention,
* Having conditions requiring the use of non-normal anesthetic agents and sedation,
* Using vasoconstrictive drugs,
* Using positioning devices,
* Undergoing prolonged surgical intervention,
* Having arterial pressure lower than 32 mmHg,
* Having diabetes mellitus requiring insulin therapy.

Primary outcomes:
measure: In collecting the data, three different data collection tools were used: "Personal Information Form"
timeFrame: 12 months
measure: Body and Ambient Temperature Record Form"
timeFrame: 12 months
measure: "Braden Risk Assessment Scale".
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hitit University
city: Çorum
country: Turkey
facility: HititU
Study officials:
affiliation: zehra86_sevgi@hotmail.com
name: Zehra UNAL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04686942: Sonazoid-enhanced Ultrasound for the Detection of Colorectal Liver Metastases Less Than 2 cm
Official title: Evaluation of Contrast Sonazoid-enhanced Ultrasound for the Detection of Colorectal Liver Metastases Less Than 2 cm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Metastasis Colon Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with one or more liver metastases lesions less than 2cm.

Brief summary: Preoperative chemotherapy is often used for patients with colorectal cancer liver metastasis (CLM). Many small CLMs (\<=2cm) may disappear after chemotherapy, while most of these are still alive. Ultrasonography (US) is a common imaging modality for the intraoperative detection tumor. Sonazoid is new echo-contrast agent, which is more stable and sensitive for detecting of small tumor. Investigators initially this prospective study to compare the detection performance before and after using sonazoid.


Eligibility criteria: Inclusion Criteria:

* Pathology confirmed colorectal adenocarcinoma
* One or more liver metastases less than 2 cm
* Multidisciplinary team recommend to perform preoperative chemotherapy
* Have baseline EOB-MR before chemotherapy

Exclusion Criteria:

* Could not fulfill the criteria of no evidence of disease (NED) after hepatic resection/ablation/radiotherapy
* With other malignancies

Primary outcomes:
measure: sensitive of detection tumor
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
Study officials:
affiliation: Sun Yat-sen University
name: Yunfei Yuan, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05803642: A Study of Olanzapine in Patients With Acute Agitation
Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Injection of Olanzapine in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar I Disorder.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Agitation
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 318
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: The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.


Eligibility criteria: Inclusion Criteria:

1. Male and female patients between the ages of 18 to 65 years, inclusive.
2. Patients who have met DSM-5 criteria for schizophrenia and bipolar I disorder.
3. Patients who are judged to be clinically acutely agitated with a total score of ≥ 14 on the 5 items comprising the PANSS-EC and at least one individual item score≥ 4 immediately before randomization.

Exclusion Criteria:

1. Patients with agitation caused by delirium, seizures, developmental delay, poisoning, etc., or withdrawal from drug abuse.
2. Patients who have had previous suicidal behavior or currently at serious risk of suicide.
3. Patients with glaucoma or at risk of angle-closure glaucoma.
4. Patients who have brain diseases such as intracranial infection, brain trauma, cerebrovascular disease, basal ganglion disease, hypoxic encephalopathy, Parkinson's disease, Parkinson's syndrome, and dementia.
5. Use of benzodiazepines, other hypnotics or short-acting antipsychotic drugs within 4 hours before randomization.
6. Treatment with psychostimulants or reserpine within one week before randomization.
7. Patients who received long-acting injections of typical or atypical antipsychotics within 2 weeks prior to randomization or within one injection interval.
8. Treatment with clozapine within 4 weeks before screening.
9. Patients with serious or unstable medical illnesses.
10. Female patients who have a positive pregnancy test at screening or are breastfeeding.
11. Patients who have participated in other clinical trials within 3 months before randomization.

Primary outcomes:
measure: Change from baseline to 2 hours post-first IM injection on the PANSS-EC
timeFrame: 2 hours
Secondary outcomes:
measure: Percentage of Participants With 40% or Greater Percent Decrease in the PANSS-EC Total Score
timeFrame: 2 hours post-first IM injection
measure: Proportion of participants receiving one, two, or three doses of study drug during 24-hour intramuscular treatment period
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05678842: Balance and Weight Distributions at Kneeling
Official title: Balance Parameters and Weight Distributions at Different Kneeling Positions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Balanced
Weight, Body
Keywords: kneeling
weight distribution
balance
lower extremity
asymmetry
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: This study aims to examine balance parameters and weight distributions at different kneeling positions.

Detailed description: A cross-sectional study design was used to describe the balance parameters and weight-bearing distributions on knee in different kneeling positions with different ankle conditions. The participants signed informed consent forms before the study was performed on a voluntary basis. Inclusion criteria were defined as being between 18-30 years old and not having knee pain with kneeling. Exclusion criteria were previous history of lower limb pain/pathology, trauma, and/or surgery, any neurological, rheumatological or oncological disorders that would affect balance, have performed high intensity physical activities last 72 hours before test day, and BMI \> 25. Balance parameters and weight distribution to each knee were evaluated three times at upright kneeling (UK) and full kneeling (FK) positions, in different ankle conditions (dorsiflexion and plantarflexion) with static balance device. Test-retest ICC values were calculated for all procedures.

Eligibility criteria: Inclusion Criteria:

* being between 18-30 years old
* not having knee pain with kneeling

Exclusion Criteria:

* previous history of lower limb pain/pathology,
* trauma, and/or surgery, any neurological, rheumatological or oncological disorders that would affect balance,
* have performed high intensity physical activities last 72 hours before test day,
* BMI \> 25

Primary outcomes:
measure: To investigate balance parameters (postural sway (mm) ) in different kneeling positions.
timeFrame: one year
measure: weight distributions (kg) in different kneeling positions.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT01516242: Evaluation of Safety and Parameters of Application Technique
Official title: Monitoring of Expected Parameters of the Application Technique and Safety of the Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 4819
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 1 diabetes or type 2 diabetes mellitus treated with insulin having changed administration of inulin from syringe to a Novo Nordisk insulin delivery system

Brief summary: This study is conducted in Europe. The aim of the study is to monitor patients changing therapy from syringe to insulin delivery system as prescribed by the treating physician in Slovakia.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus (type 1 or type 2)
* Treated with insulin

Primary outcomes:
measure: Number of insulin applications (punctures)
measure: Reasons leading to change of the therapy
measure: Patient satisfaction with NovoPen® 4 insulin delivery system
Secondary outcomes:
measure: Adverse reactions
measure: Hypoglycaemia
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT07007442: Instrument Assisted Soft Tissue Mobilization Versus Dry Cupping On Chronic Mechanical Neck Pain
Official title: Instrument Assisted Soft Tissue Mobilization Versus Dry Cupping On Chronic Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Which is more effective Instrument assisted soft tissue mobilization or Dry cupping on pain intensity, cervical range of motion and functional status in patients with chronic mechanical neck pain?

Detailed description: Neck pain is a common musculoskeletal pathology treated by physical therapists around the world. Neck pain is one of the highest complaints in terms of years lived with a disability, increasing the prelevancy of proper management by physical therapists. The overall prevalence of neck pain ranges from 10% to 20%, and the incidence of new neck pain ranging from 10% to 50%. Dry cupping involves the use of glass, plastic or bamboo cups that are placed over localized areas of skin. A vacuum suction is achieved with heat from a flame, a manual handheld pump or electrical pumping devices to create a negative pressure, drawing localized skin and soft tissue structures into the cup . Instrument-assisted soft tissue mobilization (IASTM) is a new technique, which has been known to be effective in reducing muscle tightness in athletes . IASTM is a new tool, which allows clinicians to efficiently locate and treat individuals diagnosed with soft tissue dysfunction .

The use of the instrument is thought to provide a mechanical advantage for the clinician by allowing deeper penetration and more specific treatment, while also reducing imposed stress on the hands

Eligibility criteria: Inclusion Criteria:

* 45 patients with chronic mechanical neck pain in the past 3 months.
* Age range from 18 to 35 years old.
* Patients will be from both sexes.
* Body mass index from 18.5 to 24.9 kg/m2.
* Subjects suffer from chronic mechanical neck pain.

Exclusion Criteria:

* Serious injury.
* Tumor.
* Infection.
* Spinal fractures.
* Recent cervical surgery.
* Cervical radiculopathy.
* Skin disease, allergy, hypersensitivity, any malignant or benign tumors.
* Unhealed scars or wounds.
* Pregnancy.
* Known psychiatric condition under treatment or medication.
* Any orthopedic and Neurological condition as cervical PIVD, spondylolisthesis.

Primary outcomes:
measure: Pain intensity
timeFrame: up to four weeks
Secondary outcomes:
measure: Cervical Range of motion
timeFrame: up to four weeks
Other outcomes:
measure: neck disability
timeFrame: up to four weeks
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Sahar Abdullah, Phd
role: STUDY_DIRECTOR
References:
citation: Binder AI. Neck pain. BMJ Clin Evid. 2008 Aug 4;2008:1103.
Clinical trial NCT02673242: Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Bergen University College
First posted: 2016-02-03
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled trial with the aim of evaluating the effect of homebased inspiratory muscle training (IMT) for patients with COPD in Norway. The intervention group will train with threshold IMT for 6 weeks. The control group will not participate in any other training method or sham. Evaluation parameters are maximal inspiratory pressure, six minute walk test, COPD assessment test, modified Medical research council dyspnea scale and spirometry.


Eligibility criteria: Inclusion Criteria:

* COPD grade III-IV,
* Inhabitant of Hedmark (Løten, Våler, Åsnes, Hamar, Elverum)

Exclusion Criteria:

* Undergoing exercise based physical therapy treatment,
* not able to do IMT physically or mentally

Primary outcomes:
measure: Maximal inspiratory pressure
timeFrame: 6 weeks
Secondary outcomes:
measure: Six minute walk test
timeFrame: 6 weeks
measure: Modified Medical Research Council Dyspnea Scale
timeFrame: 6 weeks
measure: COPD Assessment Test
timeFrame: 6 weeks
measure: Spirometry
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Elverum
country: Norway
facility: Sykehuset Innlandet Hospital Trust
Study officials:
References:
Clinical trial NCT05113342: Descartes-25 in Relapsed/Refractory Multiple Myeloma
Official title: Phase I/IIa Study of Descartes-25 in Patients With Relapsed/Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Relapse Multiple Myeloma
Keywords: myeloma
multiple myeloma
Relapse Refactory multiple myeloma
Lead sponsor: Cartesian Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase I/IIa dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of an allogeneic Mesenchymal Stem Cell (Descartes-25) product secreting a bispecific protein and other proteins in patients with Relapsed/Refractory Multiple Myeloma.


Eligibility criteria: Inclusion Criteria:

* 18 years and older'
* diagnosed with active R/RMM, who have failed 2 lines of treatment
* have measurable disease

Exclusion Criteria:

- Patients with active plasma cell leukemia

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Louisiana State University Health Science Center at Shreveport
state: Louisiana
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Ankara
country: Turkey
facility: Saglik Bilimleri Universitesi
state: Anatolia
Study officials:
References:
Clinical trial NCT00194142: Cytomegalovirus (CMV) Infection in Amniotic Fluid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications
Cytomegalovirus Infections
Keywords: Pregnancy
Cytomegalovirus
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 37
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The purpose of this study is to determine the prevalence of Cytomegalovirus (CMV) infection in amniotic fluid specimens obtained at 16 to 18 weeks of pregnancy and to determine if CMV infection of amniotic fluid supernatant and/or amniocytes is associated with adverse obstetric outcomes. Amniotic fluid will be obtained from an already established registry. and analyzed in conjunction with a chart review under a HIPAA Waiver of Authorization.

Brief summary: The purpose of this study is to determine if detection of cytomegalovirus (CMV) in amniotic fluid collected in the second trimester of pregnancy is associated with pregnancy complications such as preterm delivery or severe preeclampsia.

Detailed description: CMV infection in adults with a normal immune system is rarely a serious event. Once a person has been infected with CMV, they may have recurrences (relapses) of the infection. If a mother is infected with the virus or relapses during pregnancy, her fetus may be at risk for infection. Unlike infection in adults, congenital infection may result in serious complications (congenital infection). The effects of fetal infection with CMV are well understood and many efforts have been made to potentially reduce the risk of congenital infection. However, the effect of CMV infection on the pregnancy itself (when the fetus is not affected by CMV) is less understood.

The incidence of CMV detection in amniotic fluid collected in the second trimester is thought to be low. However, the association between detection of CMV infection in the second trimester and ultimate pregnancy outcome is poorly described.

In this study, we plan to determine if CMV detection in amniotic fluid collected in the second trimester is associated with pregnancy complications.

Eligibility criteria: Inclusion Criteria:

* Women who deliver at term without pregnancy complications
* Women who deliver (preterm, less than 37 weeks of gestation) as a result of spontaneous preterm labor
* Women whose pregnancies are complicated by severe preeclampsia

Exclusion Criteria:

* Women with multi-gestational pregnancies, or whose pregnancies are complicated by a congenital malformation or chromosomal abnormality
* Women who have a medical history of hypertension (high blood pressure), diabetes, or severe renal (kidney) disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Doris Chou, MD
role: PRINCIPAL_INVESTIGATOR
References: