louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06788574: Preliminary Outcome Of Tecar On Stress Urinary Incontinence, Pelvic Floor Strength And Sexual Satisfaction In Women With Vaginal Relaxation Syndrome
Official title: Preliminary Outcome Of Tecar Therapy Effect On Stress Urinary Incontinence, Pelvic Floor Strength And Sexual Satisfaction In Women Complaining Of Vaginal Relaxation Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: STRESS URINARY INCONTINENCE
VAGINAL RELAXATION SYNDROME
Keywords: Vaginal Relaxation Syndrome
Tecar Therapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forty women aged 50-60 years with a body mass index (BMI) of 25 kg/m2 to 30 kg/m2, who complain of stress urinary incontinence and vaginal laxity, will be separated randomly into two equivalent groups. In group (A) 20 women will receive TECAR therapy for 15 min and pelvic floor exercise for 20 min, while in group (B), 20 females will receive sham treatment for 15 min and pelvic floor exercise for 20 min twice per week for 8 weeks. Both groups wil be assessed using a perineometer as an assessment tool for pelvic floor muscle strength muscles and the Visual Analog Scale, ICIQ-UI short form questionnaire about the frequency of urinary incontinence symptoms, Millheiser Sexual Satisfaction Scale, and the Sexual Quality of Life Questionnaire-Female (SQOL-F) to assess sexual satisfaction by each patient before, after 4 weeks, and after 8 weeks of treatment


Eligibility criteria: Inclusion Criteria:

* participants are multipara at least two times with sexual activity for at least 1/month with normal cell cytology (PAP smear), integrity of the vaginal canal mucosa, and negative urine culture (without injuries or bleeding).

Exclusion Criteria:

* pregnancy, use of photosensitive medicines, vaginal bleeding injury or infection in the treated area, and use of an IUD.

Primary outcomes:
measure: pelvic floor muscle strength assessed using a Peritron (9300) device with a vaginal sensor
timeFrame: after 4 and 8 weeks
measure: urinary incontinence symptoms using Visual Analog Scale and ICIQ-UI short form questionnaire
timeFrame: after 4 and 8 weeks
measure: sexual satisfaction using Millheiser Sexual Satisfaction Scale, and the Sexual Quality of Life Questionnaire-Female (SQOL-F)
timeFrame: after 4 and 8 weeks
measure: Vaginal PH using PH color strips
timeFrame: at baseline, after 4 weeks, and after 8 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06837974: AI-guided TIPS Procedure
Official title: Construction and Application of an AI Model for Guided TIPS Surgical Puncture: a Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Portal Hypertension Related to Cirrhosis
Keywords: TIPS
AI
Efficacy
Complications
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 180
Sex: ALL
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: The goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (TIPS)-guided AI model can guide TIPS procedure in adults better than conventional TIPS procedure (artificially blinded TIPS). TIPS surgical outcomes and intraoperative and postoperative complications will also be observed. The main questions it aims to answer are:

* Does the AI model lower the number of punctures, radiation dose, and complications of participants undergo TIPS?
* Does the AI model improve the efficacy of TIPS for participants?

Participants will:

* Take the TIPS by the guidance of the AI model or conventional manually blinded penetration (placebo)
* The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications within 3 months will be recorded
* Intraoperative portal pressure gradient drop values, symptoms of ascites and rebleeding within 3 months after TIPS will be reported


Eligibility criteria: Inclusion Criteria:

* Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.
* Participants whose physical condition is suitable for TIPS.

Exclusion Criteria:

* Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
* Participants are pregnant or breastfeeding.
* Participants are unwilling or unable to sign informed consent.

Primary outcomes:
measure: Number of punctures
timeFrame: From the beginning to the end of the TIPS procedure.
Secondary outcomes:
measure: Radiation dose
timeFrame: From the beginning to the end of the TIPS procedure.
measure: Surgical success rate
timeFrame: From the beginning to the end of the TIPS procedure.
measure: Complications
timeFrame: From enrollment to the end of the TIPS procedure at 3 months.
Other outcomes:
measure: Portal pressure gradient
timeFrame: From the beginning to the end of the TIPS procedure.
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Jinyinhu Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union West Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT00367874: Treatment of Polydrug-Using Opiate Dependents During Withdrawal
Official title: Treatment of Polydrug-Using Opiate Dependents During Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opiate Dependence
Drug Dependence
Substance Withdrawal Syndrome
Keywords: Opiate dependence
Benzodiazepine dependence
Polydrug Abuse
Detoxification
Withdrawal Treatment
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2006-08-23
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Managed detoxification is a first and necessary step prior to treatment and rehabilitation. Detoxification can be a major obstacle for some patients, and the availability of managed and safe withdrawal is a prerequisite for long-term treatment.

In our clinical practice we have felt the need for a standardised and safe detoxification treatment regimen for our opioid addicts, as dependence on multiple drugs is so common.

Objectives

1. To assess whether a novel standardised treatment regimen - Buprenorphine (BPN) combined with Valproate (VPA) - will result in fewer withdrawal symptoms during detoxification of opiate-polydrug users than the existing treatment regimen, i.e. Clonidine (CLN) combined with Carbamazepine (CBZ).
2. To determine whether there are differences in treatment retention between the BPN/VPA and the CLN/CBZ groups.
3. To assess differences in clinical side-effects and biochemical interactions between the two treatment regimens.


Eligibility criteria: Inclusion Criteria:

- Polydrug dependency (at least opiate and benzodiazepine dependency)

Exclusion Criteria:

* No severe psychiatric illness
* No history of epilepsy seizures
* No pregnancy or breastfeeding
* Fertile women must use contraceptives

Primary outcomes:
measure: Retention in treatment
measure: Withdrawal symptoms
Secondary outcomes:
measure: Serum concentration of Valproate and Buprenorphine separately and in combination
measure: Urine testing
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sorlandet Hospital HF, Addiction Unit (ARA)
state: Vest-Agder
Study officials:
affiliation: Sorlandet Hospital HF, Addiction Unit
name: Oistein Kristensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kristensen O, Lolandsmo T, Isaksen A, Vederhus JK, Clausen T. Treatment of polydrug-using opiate dependents during withdrawal: towards a standardisation of treatment. BMC Psychiatry. 2006 Nov 15;6:54. doi: 10.1186/1471-244X-6-54.
Clinical trial NCT01923974: The Analgesic Effects of Melatonin
Official title: The Analgesic Effects of Melatonin: A Randomized, Placebo-controlled, Double-blinded Study on Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Analgesia
Antihyperalgesia
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2013-08-16
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A study investigating the analgesic effect of melatonin in a human heat injury model using quantitative sensory testing.


Eligibility criteria: Inclusion Criteria:

* Healthy males aged between 20 and 40 years

Exclusion Criteria:

* Under aged/minors
* Does not speak or understand danish
* Alcohol or abuse of medicines
* Prior QST-trial within the last 2 month
* Prior medical trail within the last month
* Serious comorbidity (ASA-class 3-4)
* Chronic pain (defined by analgesic treatment) Shift-work or night work within the last 14 days Known sleep-disorder

Primary outcomes:
measure: Pain (VAS)
timeFrame: During burn injury. 1 hours following melatonin/placebo administration
measure: Change in areas of secondary hyperalgesia
timeFrame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
Secondary outcomes:
measure: Change in erythema/oedema assessed by ultrasound
timeFrame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
measure: Thermal thresholds assessed by quantitative sensory testing
timeFrame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
measure: Mechanical thresholds assessed quantitative sensory testing
timeFrame: 1,2,4,6 hours following burn injury, which corresponds to 2,3,5 and 7 hours after melatonin/placebo-administration
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Multidisciplinary Pain Center 7612, Neuroscience Center, Rigshospitalet
Study officials:
affiliation: Herlev Hospital
name: Lars P.H. Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen LP, Werner MU, Rosenkilde MM, Harpsoe NG, Fuglsang H, Rosenberg J, Gogenur I. Pharmacokinetics of oral and intravenous melatonin in healthy volunteers. BMC Pharmacol Toxicol. 2016 Feb 19;17:8. doi: 10.1186/s40360-016-0052-2.
Clinical trial NCT02024074: Evaluation of Magnetic Resonance Imaging (MRI) vs Molecular Breast Imaging (Tc-MBI) in Breast Cancer Patients
Official title: Performance of Tc99m Sestamibi Molecular Breast Imaging (Tc-MBI) Versus Magnetic Resonance Imaging in the Diagnosis of Breast Carcinoma: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-12-31
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to evaluate the usefulness of Tc-99m Sestamibi Molecular Breast Imaging as an imaging modality for breast cancer screening.

Tc-MBI has shown significantly higher sensitivity and equivalent specificity in the detection of breast cancer among high risk women when compared to mammography. However, there is little published data comparing Tc-MBI to MRI for evaluating extent of disease in women with known breast cancer.

The study will target twenty (20) women with newly diagnosed breast cancer who are scheduled to undergo biopsy of additional suspicious lesions that were identified on standard of care contrast- enhanced breast MRI. Prior to the biopsy, these subjects will receive a Tc-MBI scan of the breast. The results from both imaging methods will be compared to histological findings. These results may be used to design larger and more comprehensive studies with an overarching goal to determine if there is a role for Tc-MBI in the pre-operative evaluation of patients with known breast cancer.


Eligibility criteria: Inclusion Criteria:

Women Patients must be 18 years of age or older. Patients will have biopsy proven unilateral breast cancer with ipsilateral or contralateral suspicious lesions on contrast-enhanced breast MRI and be a candidate for additional tissue biopsy.

Patients must be able to remain still for Tc-MBI scanning Patients must be able to provide written informed consent

Exclusion Criteria:

Men, age less than 18, inability to remain still for Tc-MBI scanning, cannot provide written informed consent, known untreated bilateral breast cancer, evidence of distant metastasis disease (M=1), pregnancy.

Primary outcomes:
measure: Cancer detection rates by Sestambi imaging
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
References:
Clinical trial NCT04301674: Metabolomics in Occupational Asthma
Official title: Pilot Study of Metabolomics in Occupational Asthma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma, Occupational
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Owlstone Ltd
First posted: 2020-03-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with occupational asthma, referred to the Unit of Environmental and Occupational medicine OUS for evaluation of OA.and healthy volunteers

Brief summary: The project aims to increase the diagnostic accuracy in occupational asthma (OA), with emphasis on Irritant Induced Asthma (IIA). Currently, most patients are evaluated in occupational medicine by comparing the exposure and symptom characteristics with epidemiological data. Biological markers may be present in AA, but presently not in IIA. The majority of cases evaluated are considered as possible IIA, i.e. low-dose multiple exposures. VOC features will be analyzed with the Breath Biopsy® and TD-GS-MS (Owlstone Medical Ltd, UK).


Eligibility criteria: Inclusion Criteria:

* capable of informed consent.
* asthma diagnosis established by lung specialist or healthy control.

Exclusion Criteria:

* skin allergy towards plastics or rubber.
* immunocompromised by oral medication.
* contagious respiratory disease.
* biopsy of lung parenchyma within the last 36 hours.

Primary outcomes:
measure: Discovery of VOC Biomarkers in Asthma
timeFrame: Baseline
measure: Discovery of VOC Biomarkers in Occupational Irritant Asthma
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Bato Hammarstrøm, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Tonje Trulssen Hildre, M.Sc.
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Hilde Heiro, MD
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Britt G Randem, MD/PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01714674: Nitrate and Exercise-induced Cardiac Troponin T in Type 2 Diabetes
Official title: The Impact of Dietary Nitrate Supplementation on Exercise-induced Cardiac Troponin T Release in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: cardiac troponin T
cTnT
exercise
dietary nitrate
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-10-26
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Blood cardiac troponin T (cTnT) concentration is a widely used marker of acute cardiac injury. Previous research has shown that type 2 diabetic patients may experience large increments in cTnT levels over the subsequent hours following a single bout of moderate-intensity endurance-type exercise. This phenomenon is likely attributed to cardiac ischemia-reperfusion injury caused by reduced nitric oxide (NO) bioavailability. Recent evidence indicates that ingestion of dietary nitrates dramatically increases the bioavailability of NO, and as such, may be protective against cardiac ischemia-reperfusion injury.

The investigators hypothesize that dietary nitrate supplementation blunts the rise in cTnT levels following exercise in type 2 diabetic patients.


Eligibility criteria: Inclusion Criteria:

* exercise-induced cTnT release (\>3ng/L)

Exclusion Criteria:

* HbA1c \<6.0% or \>10.0%
* morbid obesity (BMI\>35 kg/m2)
* incident cardiovascular events in the last year (heart attack, stroke
* use medication which contain nitrates and/or having vasodilatory effects

Primary outcomes:
measure: Cardiac troponin T
timeFrame: 9 hours, hourly time intervals
Secondary outcomes:
measure: Plasma nitrate
timeFrame: 9 hours, hourly time intervals
measure: Plasma nitrite
timeFrame: 9 hours, hourly time intervals
measure: Blood pressure
timeFrame: day
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
Study officials:
affiliation: Maastricht UMC
name: Luc van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01588574: Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Dystonia
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 60
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 determine the Optimal dose for safety and efficacy in the treatment of cervical dystonia.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18\~75
* Have no clinically significant medical condition
* Cervical dystonia

Exclusion Criteria:

* Pregnant or lactation
* Subjects who have been administered the following drugs within the previous 1 month

Primary outcomes:
measure: Number of adverse events
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
Study officials:
References:
Clinical trial NCT03706274: PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients With Solid Tumors
Official title: A Phase 1, Open-Label, Dose-Ranging Study of the PD-1 Probody Therapeutic CX-188 in Adults With Recurrent or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: CytomX Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-10-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this first-in-human study of CX-188 is to characterize the safety, tolerability, pharmacokinetics (PK), and antitumor activity of CX-188 in adult subjects with metastatic or advanced unresectable solid tumors that progressed on standard therapy: PROCLAIM: PRObody Clinical Assessment in Man CX-188 clinical trial 001


Eligibility criteria: Inclusion Criteria:

1. histologically confirmed diagnosis of metastatic or advanced unresectable solid tumors that progressed on standard therapy
2. agreement to provide mandatory archival tumor or fresh biopsy before they can be considered for inclusion in the study 3. At least 18 years old

Exclusion Criteria:

1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic
3. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C
4. History of or current active autoimmune diseases
5. History of syndrome or medical condition(s) that requires systemic steroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications
6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant
7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug
8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug

Primary outcomes:
measure: The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-188 as a monotherapy
timeFrame: 21 days
Secondary outcomes:
measure: The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
Study officials:
affiliation: CytomX Therapeutics
name: Yifah Yaron, MD
role: STUDY_DIRECTOR
References: