louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02813174: Personality Style and Self Compassion in Postpartum Depression: An Online Prevention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: i4Health
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to assess the relationship between personality style, self-compassion and depression during pregnancy, to identify psychological risk factors, particularly personality styles, that may contribute to the onset of PPD. Additionally, the study will provide support for the effectiveness of Internet-based Compassionate-Mind Training (iCMT) as a prevention intervention for Postpartum Depression (PPD) for women in the 2nd and 3rd trimester of pregnancy. The study will also assess differences along personality predictors and depression severity as they relate to intervention outcomes (i.e. depression in postpartum and self-compassion) and engagement. The researchers hypothesize that women both at high and low risk for PPD will receive benefits from the intervention, however, those who endorse more maladaptive personality traits will likely engage and benefit less than those who do not endorse these traits.


Eligibility criteria: Inclusion Criteria:

* Pregnant women in the second and third trimester

Exclusion Criteria:

* Under 18 years of age
* Males
* Women who are not pregnant
* Pregnant women in the first trimester of pregnancy or over 36 weeks pregnant
* Women who likely meet criteria for a Major Depressive Episode
* Women currently in in-person psychological tx

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: Change from baseline depression at 6 and 12-weeks postpartum
measure: Vulnerable Personality Style Questionnaire
timeFrame: At baseline
measure: Self Compassion Scale
timeFrame: Change from baseline self-compassion at two weeks post-baseline, and 6 and 12-weeks postpartum
Secondary outcomes:
measure: Mini-markers
timeFrame: At baseline
measure: Postpartum Depression Predictors Inventory - Revised
timeFrame: At baseline
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto University
state: California
Study officials:
References:
Clinical trial NCT05697874: International Rare Brain Tumor Registry
Official title: International Rare Brain Tumor Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Astroblastoma
BCOR ITD Sarcoma
CNS Sarcoma
Unclassified Tumor, Malignant
Keywords: Rare Brain Tumor
Pediatric Brain Tumor Registry
Unclassifiable tumor
Pediatric Neuro-Oncology
Rare Disease
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 5800
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include patients who have completed the informed consent process and are \<= to 45 years of age at diagnosis of the following: CNS Sarcoma, BCOR-altered tumor, Astroblastoma/MNI-1 altered tumors, histologically ambiguous/unclassifiable brain tumor, rare brain tumor. Patients from anywhere in the world are eligible for enrollment.

Brief summary: The objective of the International Rare Brain Tumor Registry (IRBTR) is to better understand rare brain tumors through the collection of biospecimens and matched clinical data of children, adolescents, and young adult patients diagnosed with rare brain tumors.

Detailed description: The International Rare Brain Tumor Registry (IRBTR) is a prospective observational study that will collect tumor samples and matched clinical and radiological data to better understand the outcomes of patients with rare brain tumors in particular: CNS sarcoma, BCOR, MN-1 altered tumors, and other unclassified rare brain tumors.

Data collected include demographics, disease characteristics, treatment information, radiological imaging, and biospecimen collection if available ( tumor tissues Patients will be followed longitudinally to obtain outcome data. Data collection will continue for approximately 10 years.

Eligibility criteria: Inclusion Criteria:

* Patients with a known or suspected CNS Sarcoma.
* Patients with a known or suspected BCOR-altered brain tumor
* Patients with a known or suspected Astroblastoma/NM-1 altered brain tumor
* Patients with known or suspected histologically ambiguous/unclassifiable brain tumor
* Patients with a known or suspected rare brain tumor.
* Signed informed consent by patient/ parent or guardian (assent where applicable) to participate in the study.

Exclusion Criteria:

* The patient has an extra-CNS primary tumor.
* The patient is older than 46 years of age at diagnosis.
* The patient or family is not willing to participate or does not sign informed consent.

Primary outcomes:
measure: Event-free Survival
timeFrame: 10 years
Secondary outcomes:
measure: Molecular characterization
timeFrame: 10 years
measure: Radiological characterization
timeFrame: 10 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
affiliation: afonsecash@childrensnational.org
name: Adriana Fonseca, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942474: Nerve Access Tool Study
Official title: A Prospective, Non Randomized, Single-center, Non-blinded Feasibility Study Examining the Use of a Nerve Access Tool
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cystocele
Keywords: The focus of the study is to assess the ability of the nerve access tool to facilitate nerve lead placement
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2009-07-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.


Eligibility criteria: Inclusion Criteria:

* Subject is equal to or greater than 18 years of age
* Subject has a diagnosis of cystocele with planned surgical repair
* Subject has no known deficit of the nerve
* Subject is willing and able to provide written informed consent and HIPAA authorization to participate by signing the Informed Consent/Health Insurance Portability and Accountability Act Form after a full explanation of the nature and purpose of this study
* Subject is willing and able to comply with the study protocol

Exclusion Criteria:

* Subject has known neurological abnormalities of the nerve
* Subject has a known allergy to the tool or neurostimulation lead components
* Subject is pregnant or lactating

Primary outcomes:
measure: Electromyography Response
timeFrame: Implant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00948974: Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
Official title: Variations of Cognitive Behavior Therapy for Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: social anxiety
treatment
Cognitive Behavioral Therapy
Acceptance and Commitment Therapy
Cognitive Therapy
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 88
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 compare the efficacy of two variants of cognitive behavioral therapy (CBT) (cognitive therapy (CT) and acceptance and commitment therapy (ACT)), for the treatment of generalized social anxiety disorder.

Detailed description: We are recruiting a clinical sample of patients who meet diagnostic criteria (per DSM-5) for the generalized subtype of social anxiety disorder. Participants are randomly assigned to the two active intervention conditions; no placebo or sham treatments will be employed. Assessments take place at baseline, pre-treatment, mid-treatment, post-treatment, and at 3- and 12-months follow-up; participants also complete a brief weekly assessment of functioning. Treatment is administered individually by trained graduate students in clinical psychology, directly trained and supervised by the PI and Co-PI. Participants receive 12 weekly 1-hour long sessions. The study design is a 2 (treatment condition) by 5 (assessment occasion) mixed factorial design.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosable social anxiety disorder (generalized subtype per DSM-IV-TR criteria)
* aged 18-65
* working fluency in English
* residence in the greater Philadelphia area.

Exclusion Criteria:

* Pervasive developmental disability
* acute suicide potential
* inability to travel to the treatment site
* schizophrenia or other psychotic disorder
* current substance dependence
* Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of social anxiety disorder.

Primary outcomes:
measure: Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale
timeFrame: baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)
Secondary outcomes:
measure: Outcomes Questionnaire
timeFrame: baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks)
measure: Behavioral Assessment Test
timeFrame: baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: James D. Herbert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00665574: ActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee
Official title: A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of ActaVisc and ActaVisc Mx Intra-articular Injection for Management of Pain Associated With Osteoarthritis in the Knee.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Carbylan Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis (OA) grade 2 or 3.
* Symptoms in the treatment knee for at least 12 months.
* Fully ambulatory patient.

Exclusion Criteria:

* Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
* Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.

Primary outcomes:
measure: Change from Baseline in the WOMAC Pain subscale average score for the treatment knee.
timeFrame: 26 weeks post treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Daugavpils
country: Latvia
facility: Daugavpils Pilsetas Centrala Slimnica
city: Riga
country: Latvia
facility: State Hospital of Traumatology and Orthopaedics
Study officials:
References:
Clinical trial NCT06158074: Efficacy of Electrical Pudendal Nerve Stimulation and Sacral in Treating Non-obstructive Neurogenic Urinary Retention
Official title: Efficacy of Electrical Pudendal Nerve Stimulation and Sacral Neuromodulation in Treating Non-obstructive Neurogenic Urinary Retention: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
Collaborators: name: Shanghai Pudong Hospital of TCM
First posted: 2023-12-06
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe the clinical effects and make a comparative study between efficacy of electrical pudendal nerve stimulation (EPNS) and sacral neuromodulation (SNM) , evaluate the advantages of EPNS in the treatment of neurogenic non-obstructive urinary retention, and provide a new method for the treatment of the disease.


Eligibility criteria: Inclusion Criteria:

* Non-mechanical obstructive urinary retention occurs following relevant neurological system disorders (spinal cord injury, spina bifida，myelitis, cervical/thoracic disk disease, lesion following spinal anesthesia/spine surgery,lumbar/sacral spine intervertebral disc diseases, spinal stenosis, iatrogenic pelvic nerve lesions, sacral agenesis, peripheral neuropathy due to diabetes mellitus).
* With normal upper urinary tract function.
* Other therapies and medications potentially affecting the assessment of this therapy have been discontinued for at least two weeks before the interventional procedure.
* Patient with good compliance who is capable of cooperating with the follow-up requirements

Exclusion Criteria:

* Patients with any suprapontine and pontine lesions
* Pregnant or lactating women
* Individuals whose symptoms show significant improvement after pharmaceutical and adjunctive therapy
* Individuals with concurrent acute or chronic prostatitis, prostate cancer, or conditions such as bladder neck stenosis, urethral stricture, or urethral injury
* High pathological risk factors (e.g., lymph node metastasis, resection margin involvement, bulky tumors)
* Individuals with concomitant obstructive urinary retention

Primary outcomes:
measure: Bladder residual urine volume measured by ultrasound
timeFrame: T0 (baseline); T1 (week 2); T2 (week 4)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai research institute of acupuncture and meridian
Study officials:
References:
Clinical trial NCT05419674: Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection
Official title: Ten-day Amoxicillin-containing Dual Therapy as First-line Helicobacter Pylori Treatment in Elderly Patients: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: dual therapy
bismuth-containing quadruple therapy
Helicobacter Pylori
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 393
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.


Eligibility criteria: Inclusion Criteria:

1. having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹⁴C-urea breath test and/or biopsy；
2. underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment；
3. with no historical treatment for helicobacter pylori infection.

Exclusion Criteria:

1. administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion
2. with previous esophageal or gastric surgery
3. with severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
4. allergy to any of the study drugs
5. participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher

Primary outcomes:
measure: Helicobacter pylori Eradication Rate
timeFrame: Six to eight weeks after completion of the medication
Secondary outcomes:
measure: Rate of Adverse Drug Reaction(ADR)
timeFrame: Within 7 days after completion of therapy
measure: Compliance Rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT03077074: Brain Responses to Visual Food Cues in Response to a Low Carbohydrate Diet
Official title: Brain Responses to Visual Food Cues in Response to a Low Carbohydrate Diet
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Changes in Functional MRI
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to profile and elucidate the hormonal and neurological system interaction to food related behavior. The stimulus used will include visual and taste (gustatory) stimuli. The study will profile induced correlations of metabolic parameters, gut hormones and brain region (ROI - regions of interest) activation and interaction. In this study we will use fMRI (functional MRI) to compare brain responses in obese, normal-weight and reduced weight subjects. The food stimuli will be blocked into specific categories to allow for investigation of different responses to alternating energy density foods. The response will be tested prior to and following a brief low carbohydrate dietary regimen.

Detailed description: The study will be a longitudinal study where the participants will come back twice on the same phase of the period- both visits in the luteal phase with a month between each visit. In this part of the study there will be 40 participants with a wider range of BMI. This phase of the study will include a nutritional intervention - the participants will be asked to have a carbohydrate restricted diet (60 grams of carbohydrate)- for a period of a month with no caloric restriction. Food records will be kept and followed and a ketone test (blood test) will be done on the morning of the study visits.

Eligibility criteria: Inclusion Criteria:

* Age 18- 45 years
* No contraindication to enter the MRI
* No significant visual problems that may hamper visualization of visual stimuli within the magnet
* No contraceptive hormonal replacement
* relatively regular menstrual cycle

Exclusion Criteria:

* contraceptive hormonal replacement
* under the age of 18
* over the age of 45
* pharmacological treatment that can effect brain response
* Irregular menstrual cycle

Primary outcomes:
measure: fMRI:(Functional MRI) changes in activation patterns of reward associated regions will be assessed prior and after dietary intervention
timeFrame: fMRI will be preformed in the luteal menstrual phase at two time points (at least a month apart). a comparison will be made between pre and post intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem Region
country: Israel
facility: Hadassah hebrew university
Study officials:
affiliation: Hadassah Medical Organization
name: Ram Weiss, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06171074: Study of CM310 in Subjects With Seasonal Allergic Rhinitis
Official title: A Multicenter, Single Arm Phase II Clinical Study Evaluating the Efficacy of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, single arm phase II clinical study mainly evaluating the efficacy of CM310 in patients with seasonal allergic rhinitis.

Detailed description: Allergic rhinitis (AR) is a non infectious chronic inflammatory disease of the nasal mucosa that is mainly mediated by immunoglobulin E (IgE) in atopic individuals exposed to allergens.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-65.
* Understand the study and sign the Informed Consent Form voluntarily.
* Take effective contraception measures throughout the study period.

Exclusion Criteria:

* Used other investigational drugs.
* Allergies to drugs with IL-4Rα monoclonal antibody or drug components of CM310.
* Plan to participate in other studies during this clinical trial.
* With malignant or benign tumors of the nasal cavity.
* Other reasons the researcher believes that the subject is not suitable to participate in this study.

Primary outcomes:
measure: Changes from baseline mean of daily retrospective total nasal of symptom score (rTNSS)
timeFrame: Up to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tong-Ren hospital
Study officials:
affiliation: Beijing Tong-Ren hospital
name: Luo Zhang
role: PRINCIPAL_INVESTIGATOR
References: