louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02989623: Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA
Official title: A Pilot Phase I Open Label Study of Cu-64-TP3805 PET Imaging for Detection of Prostate Cancer in Men With Persistently Elevated PSA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2016-12-12
Enrollment: 25
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography (PET) works in detecting prostate cancer in patients with persistently elevated prostate specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound made of a radioactive agent attached to a molecule that looks like a hormone that binds to cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able to see tumors at an earlier stage than the standard of care.

Detailed description: PRIMARY OBJECTIVES:

I. To assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect prostate cancer (PC), or absence thereof, within the prostate gland.

Eligibility criteria: Inclusion Criteria:

* Ability to provide signed informed consent and willingness to comply with protocol requirements
* Persistently elevated PSA
* Scheduled for magnetic resonance imaging (MRI) fusion/transrectal ultrasound (TRUS) biopsy, followed by histology
* Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection

Exclusion Criteria:

* Participating would significantly delay the scheduled standard of care therapy
* Administered a radioisotope within 10 physical half-lives prior to study drug injection
* Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study

Primary outcomes:
measure: Prostate Cancer Detection Within the Prostate Gland by Copper Cu 64 TP3805 PET
timeFrame: At 3 weeks post imaging visit
Secondary outcomes:
measure: Total Incidence of Multiple Lesions in an Individual Patient
timeFrame: At 3 weeks post imaging procedure
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Madhukar Thakur, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02749123: Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis
Official title: Comparison of Prescription Lidocaine Patch to Over the Counter Lidocaine Patch and Placebo for Back Pain and Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Back Pain
Arthritis
Lead sponsor: J.A.R. Laboratories
Sponsor class: INDUSTRY
First posted: 2016-04-22
Enrollment: 100
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: A comparison of transdermal patches for efficacy, side effects and quality of life for patients with back pain and arthritis. The three arms in the trial were; prescription strength lidocaine 5%, over the counter lidocaine 3.6%, menthol 1.25% and placebo.

Detailed description: In this comparison of; lidocaine 5%, lidocaine/menthol 1.25% and placebo for patients with back pain and arthritis, subjects had to qualify by meeting various inclusion and exclusion criteria. Subjects signed an informed consent and were randomized in a double blinded fashion to one of the three arms. After randomization subjects completed a baseline questionnaire regarding how pain affects their lives. Then they began therapy with their blinded product. This same questionnaire was administered after the second day of therapy and after the final day on day 10. Responses at the day two and ten endpoints were compared to baseline to access the response of each arm.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of back pain
* Diagnosis of arthritis

Exclusion Criteria:

* Pregnancy or expected pregnancy in the next three months
* Allergic to any lidocaine, menthol and methylparaben
* No reliable access to the internet
* Baseline average pain intensity of 1,2,9 or 10 on a scale of 0-to 10.
* Pain on the area of the body not conducive to patch therapy (eg fingers, toes etc)

Primary outcomes:
measure: Efficacy comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
timeFrame: Day ten
Secondary outcomes:
measure: Quality of life comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
timeFrame: Day ten
measure: Efficacy comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
timeFrame: Day 10
measure: Side effect comparison of placebo and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
timeFrame: Day 10
measure: Side effect comparison of lidocaine 5% and lidocaine 3.6%, menthol 1.25% as measured by VAS numeric 0-10 pain scale
timeFrame: Day 10
Other outcomes:
Locations:
city: Barrington
country: United States
facility: Advocate Good Sheppard Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT05674123: Evaluating the Safety and Effectiveness of the Flex Robotic System for the Surgical Removal of Colorectal Lesions
Official title: Feasibility of Transanal Robot-Assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-01-06
Enrollment: 2
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This clinical trial assesses the safety and effectiveness of a new device called the Flex Robotic System in the surgical removal (resection) of colorectal lesions. When an area of abnormal tissue called a lesion is found in the colon or rectum, it is often not known if the lesion is cancerous or non-cancerous. Recommendation to remove the lesion may be made. Current methods of resection can be challenging and time-consuming. The Flex Robotic System is a new device that provides a stable working environment, better ability to grasp and cut lesions, and better tissue handling when performing a resection. The Flex Robotic system may be more effective at removing colorectal lesions than standard resection techniques.

Detailed description: PRIMARY OBJECTIVE:

I. To assess the rates of complete en bloc resection and adverse events of the Flex Robotic System for distal colorectal lesions.

OUTLINE:

Patients undergo resection with Flex Robotic System on study. Patients also undergo colonoscopy with or without rectal endoscopic ultrasound at screening.

Eligibility criteria: Inclusion Criteria:

* Age \>= 22 years (minimum age approved for use)
* Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classification
* Colorectal lesions situated between 5 and 15 cm from the dentate line
* Colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter
* Colorectal subepithelial lesions \< 2 cm in size
* Absence of uncorrectable bleeding disorder or coagulopathy
* Platelet count \> 50,000
* International normalized ratio (INR) \< 1.5
* Ability to give informed consent

Exclusion Criteria:

* Inability to receive general anesthesia
* Presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy)
* Excavated (0-III) colorectal lesions according to Paris classification
* Suboptimal colon preparation
* Clinical discretion of the provider

Primary outcomes:
measure: Rates of complete en bloc resection
timeFrame: Up to 2 years
measure: Incidence of adverse events
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Louis M Wong Kee Song
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03204123: PSMA PET Imaging of Recurrent Prostate Cancer
Official title: PSMA PET Imaging of Recurrent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Adenocarcinoma
Prostate Cancer
Keywords: prostate cancer
prostatectomy
biochemical recurrence
Ga-HBED-iPSMA
16-306
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 1171
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if a new diagnostic research agent named 68Ga-HBED-CC-PSMA can show prostate cancer on a PET/CT scan that cannot be seen on other standard imaging even when the PSA levels are very low.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven adenocarcinoma of the prostate
* Initially treated with definitive local therapy (surgery and radiation therapy are the most common treatments, but other treatments are also eligible)
* For patients initially treated with surgery, radiation therapy, brachytherapy, or cryotherapy:

  * PSA ≥ 0.2 ng/mL in at least two consecutive tests within 6 months of date of consent for patients
  * Note: The most recent PSA value must be within 6 weeks of consent
* For patients who have received additional treatment in the recurrent or metastatic setting:

  ° PSA ≥ 2 ng/ml above the most recent therapy nadir
* Age ≥ 18 years
* Patient must be able to tolerate PET/CT or PET/MR imaging

Exclusion Criteria:

* Patient with claustrophobia that would preclude PET/CT or PET/MR imaging or other contraindications to CT imaging.

Primary outcomes:
measure: Disease localization by PSMA PET/MR
timeFrame: 2 years
Secondary outcomes:
measure: PSA relapse free survival in patients undergoing PSMA PET/MR guided SRT
timeFrame: 2 years
measure: Incidence of Treatment-Emergent Adverse Events assessed by common terminology criteria for adverse events (CTCAE v4.0)
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only )
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heiko Schöder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00893750: Trauma and Truth Interventions (NET) Versus Conflict Resolution and Social Skills Trainings for Vulnerable Youths in Northern Uganda
Official title: Effects of Trauma-Therapy and Truth Education, Conflict Resolution and Social Skills Trainings and Traditional Ways of Coping in Northern Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Depression
Aggression
Keywords: Vulnerable Youths in Northern Uganda
Formerly Abducted Children
Reintegration and Reconciliation
Trauma Treatment
Narrative Exposure Therapy
Reconciliation
Revenge Feelings
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: More than 300,000 children are fighting in armed conflicts all over the world. In Uganda an estimated number of 25,000 children have been abducted and forced to fight or work as porters and sex slaves on the side of the rebels during the conflict between the Lord's Resistance Army (LRA) and the Ugandan government. Each year, thousands of former child soldiers have returned to their communities after they had fled or were freed from the rebels. It is well known that a high percentage of these youths are suffering from mental health problems. This could be one of the possible reasons why they are facing difficulties to reintegrate into their communities.

The main aim of the proposed project is two-fold. On the one hand, the investigators want to systematically explore the relationship between mental health and important variables for reintegration into the communities like aggression, hostility, feelings of revenge, compromises and conflict behaviour and readiness for reconciliation in formerly abducted and other vulnerable youth (orphans, child mothers and handicapped youths) in Northern Uganda. On the other hand, the investigators want to probe the efficacy of existing and newly developed interventions for formerly abducted and other vulnerable youths that are supposed to foster their mental well-being as well as their reintegration into the society and therewith are part of the long-term prevention of new conflicts in Northern Uganda.


Eligibility criteria: Inclusion Criteria:

* for individual NET Treatment: PTSD diagnosis
* for group interventions: all youths in the selected vocational training centres will be included

Primary outcomes:
measure: PTSD Symptoms and Functional Level
timeFrame: 6-months and 12-months follow-up
Secondary outcomes:
measure: Aggression Reconciliation Re-Integration Conflict and Compromise Behaviour
timeFrame: 6-months and 12-months follow-up
Other outcomes:
Locations:
city: Gulu & Kitgum
country: Uganda
facility: Vivo
Study officials:
References:
Clinical trial NCT01704950: Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial
Official title: Clinical Outcome of Defect Reconstruction Using IDRT Single Layer : Results From a Prospective Multicentric Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Wound
Reconstruction Wound
Lead sponsor: Integra LifeSciences Services
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Global population

Brief summary: The aim of this study is to provide data and the guidelines for the use of IDRT SL in small wounds, acute and chronic (less than 6 months), showing the benefits and the easy to use of this product as a one stage procedure.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient with 1 traumatic wound (burns included) or 1 reconstruction wound (oncological wounds included)
* Patients for whom the surgeon has recommended that an INTEGRA® SL matrix be implanted (even if the patient is not taking part in the study) with a Split Thickness Skin Graft in the same operating procedure
* Wound treated with only one layer of a maximum size 10cm\*12.5cm

Exclusion Criteria:

* Immunosuppressed patient
* Chronic wound (with no healing since 6 months)
* Addition of any substances (growth factor, stem cells,...) in the IDRT SL during the surgery
* Patient with a corticoid treatment with a daily dose greater than 5 mg
* Patients whose life expectancy is less than 12 months
* Patients whose mental health or health condition (Visual deficiency, Alzheimers...) would compromise completion of the self-evaluation questionnaires
* Patient with an hypersensitivity to bovine collagen, chondroitin
* Patient with clinical signs of infection (fever, pain, colour, swelling,...) and for whom the investigator diagnosed infection

Primary outcomes:
measure: Rate of graft take
timeFrame: Day 15 after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: St Josef Hospital
city: Athens
country: Greece
facility: General State Hospital of Athens, "G. Gennimatas" - Department of Plastic Surgery-Microsurgery and Burn Center
city: Udine
country: Italy
facility: University Hospital "S. Maria della Misericordia" - Plastic Surgery and Burn Center
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital - Burn and Plastic Surgery
Study officials:
affiliation: General State Hospital of Athens, "G. Gennimatas"
name: Stefanos Papadopoulos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05976308: Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
Official title: Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome : a Double-blind, Randomized and Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Jiangxi University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) is a common reproductive disease associated with endocrine and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial for PCOS, but the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. Therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of Chinese herbal medicine (Bushen Huatan Decoction) in women with PCOS.


Eligibility criteria: Inclusion Criteria:

1. The diagnosis of PCOS is based on the Rotterdam criteria.
2. Meet the syndrome differentiation standard of kidney-yang deficiency with phlegm-dampness and blood stasis in TCM theory.
3. women aged 18-40 years without fertility requirements.
4. A willingness to undergo this treatment plan.

Exclusion Criteria:

1. Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart).
2. Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L.
3. Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/mL or more than 5.5 mIU/mL.
4. Suspected Cushing's syndrome.
5. Adrenal or ovarian tumors secreting androgen.
6. Poorly controlled type II diabetes.
7. Pregnancy or lactation.
8. Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmHg or a diastolic blood pressure more than 100 mmHg).
9. Those who had taken hormones or other drugs during the previous 3 months.
10. Acute heart, liver, kidney or blood diseases.

Primary outcomes:
measure: Ovulation rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
state: Jiangxi
Study officials:
References:
Clinical trial NCT00490308: The Influence of Estradiol Supplementation During the Luteal in Patients Undergoing IVF Treatment
Official title: Blinded Randomised Trial About the Influence of Estradiol Supplementation During the Luteal in Patients Undergoing in Vitro Fertilization (IVF) Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Infertility
Keywords: luteal
phase
estradiol
pregnancy
rate
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-06-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate whether treatment with Estradiol supplementation during the luteal phase improves IVF outcomes

Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a GnRH analog will receive 4 mg estradiol valerate in the luteal phase.Patient's followup will include E2 progesterone and BHCG 14 days after embryo transfer and vaginal ultrasound on day 21 and 28 after embryo transfer

Detailed description: The study will include Patients undergoing IVF treatment with controlled ovarian hyperstimulation using a daily GnRH analog in a long protocol,older then 18, .The women will be randomised to two groups.Both groups will be given vaginal tabs of natural micronized progesterone(Uterogestan)

The study group will be given oral estradiol Valerate 4 mg.Prior to treatment, each patient will be signed on informed concent.

Patients will be excluded if they are older than 40, have any systemic illnesses or a personal or family history of a thromboembolic event.

Follow up:

Verification of pregnancy status and hormonal profile will be carried out on day fourteen after embryo transfer by means of serum hCG,P and E2. clinical pregnancy will be defined as the presence of a gestational sac on ultrasonography on day 21 after embryo transfer and fetal heart will be evaluated on day 28

Eligibility criteria: Inclusion Criteria:

* Women treated for infertility with controlled ovarian hyperstimulation using daily GnRH agonist

Exclusion Criteria:

* Women younger then 18 or older then 40
* Women with systemic disease
* Women with a family or personal history of thromboembolic event

Primary outcomes:
Secondary outcomes:
measure: E2 and progesterone levels
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Infertilty unit, Assaf-Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Rephael Ron-el, profesor
role: PRINCIPAL_INVESTIGATOR
References: