louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06431672: Perinatal Interpersonal Psychotherapy Group for Distressed Women
Official title: The Feasibility and Effects of Perinatal Interpersonal Psychotherapy Group for Distressed Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Social Adjustment
Keywords: feasibility
group psychotherapy
interpersonal psychotherapy
maternal depression
perinatal adjustment
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 258
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored.

Detailed description: This is the first perinatal interpersonal psychotherapy group (P-IPTG) implemented for distressed women from pregnancy to postpartum. The feasibility and effects of P-IPTG are explored. The third-trimester women were recruited as intervention and control group participants by a quasi-experimental design.

Eligibility criteria: Inclusion Criteria:

* women in the third trimester of pregnancy, at least 20 years old, able to read and write in Chinese, and "depressed, anxious, or wishing to improve family relationships."

Exclusion Criteria:

* women with schizophrenia, substance use, or suicide risk.

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale
timeFrame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
measure: Dyadic Adjustment Scale
timeFrame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
measure: Social Network Interaction System Questionnaire (SNISQ, Lay & Liu, 1996)
timeFrame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
measure: Satisfaction with Interpersonal Relationships Scale (Chan et al., 2002)
timeFrame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
measure: Mother-Infant Bonding Inventory (Shieh et al., 2015)
timeFrame: the seventh to ninth month in pregnancy, four month postpartum, eight month postpartum,twelve month postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Chung Shan Medical University, Taiwan
name: Peyling Shieh, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595972: Epirubicin Cisplatin and Fluorouracil (FU) Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer
Official title: Phase II Trial of Epirubicin Cisplatin and FU Combined With Endostar in Patients With Advanced or Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Time to Progression
Overall survival
Response rate
Quality of Live
Toxicities
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 study is to evaluate the efficacy and tolerability of the ECF regimen (epirubicin, cisplatin and FU) combined with endostar-- a inhibitor of angiogenesis, in patients with advanced or metastatic gastric cancer (A/MGC).

Detailed description: Although there is no standard regimen in the treatment of metastatic gastric cancer, ECF regimen (epirubicin, cisplatin and FU) is often considered as a reference regimen. And ECF regimen has been suggested as the first line therapy for A/MGC by FDA. According to the result of a Chinese phase III clinical trial in metastatic lung cancer, endostar-- a new angiogenesis inhibitor prolonged the overall survival, time to progression and improved response rate. So we designed this clinical trial to evaluate whether endostar can bring survival benefits to patients with advanced and metastatic gastric cancer patients.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
* ECOG performance scale ≤ 2
* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
* Adequate hepatic, renal, heart, and hematologic functions (platelets\>80×109/L, neutrophil\> 2.0 × 109/L, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(ULN), and serum transaminase ≤ 2.5×the ULN)

Exclusion Criteria:

* Pregnant or lactating women
* Concurrent cancer
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Neuropathy, brain, or leptomeningeal involvement
* Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
* Uncontrolled significant comorbid conditions and previous radiotherapy

Primary outcomes:
measure: time to progression
timeFrame: every two cycles
Secondary outcomes:
measure: toxicity
timeFrame: 3 weeks
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Li, PhD, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01487772: Improving Quality of Care for Hip-Fracture Patients: Studies on Fast-track Surgery
Official title: Improving Quality of Care for Hip-Fracture Patients: Studies on Fast-track Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 1307
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hip-fracture patients admitted to the Orthopaedic Department of Danderyd Hospital during a two-year period.

Brief summary: The aims of the studies are to examine the impact of delayed time to surgery for hip-fracture patients with regard to in-hospital complication rate and one-year mortality and to evaluate two different fast-track systems for hip-fracture patients with regard to patient outcome, complication rate and patient satisfaction.

Detailed description: The aims of the studies are to examine the impact of delayed time to surgery for hip-fracture patients with regard to in-hospital complication rate and one-year mortality and to evaluate two different fast-track systems, the hip process pathway and the ambulance process pathway, for hip-fracture patients with regard to patient outcome, complication rate and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Hip fracture

Exclusion Criteria:

* Periprosthetic fractures
* Pathological fractures

Primary outcomes:
measure: Complication rate
timeFrame: 3-months
Secondary outcomes:
measure: Mortality rate
timeFrame: 1-year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: Danderyd Hospital, Stockholm, Sweden
name: Olof Skoldenebrg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04781972: Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
Official title: Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: ADHD - Combined Type
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a double-blind cross over of a single dose of methylphenidate (10mg or 15mg) and matching placebo.
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators' goal is to develop neuroimaging biomarkers to predict response to treatment with methylphenidate, which then can be used in the development of novel pharmacological treatments for attention-deficit/hyperactivity disorder (ADHD). The overall objective of this study is to measure the changes in task-related neural activity related to symptoms of ADHD (measured by functional MRI) and brain glutamate levels (measured by magnetic resonance spectroscopy, MRS) after treatment with methylphenidate (MPH). This will be a double-blind crossover of methylphenidate and placebo in adults with ADHD. Participants will complete neuropsychological testing along with fMRI and MRS scans after a single dose of each treatment.


Eligibility criteria: Inclusion Criteria:

* right handed

Exclusion Criteria:

* pregnant or breast feeding
* past or current neurological disorder
* non-ADHD cause of cognitive impairment
* uncontrolled medical disorder
* head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma
* having an adverse reaction to methylphenidate, or other stimulant medication
* having a contraindication to MRI
* current smoking

Primary outcomes:
measure: BOLD signal during response inhibition
timeFrame: Approximately 90 minutes after dose
measure: Glutamate level in the anterior cingulate cortex
timeFrame: Approximately 2 hours after dose
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Kristin L Bigos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05785572: Effect of Radiofrequency of Suprascapular Nerve in Shoulder Reverse Arthroplasty
Official title: Study on the of Preoperative Analgesia With Radiofrequency of Suprascapular Nerve Versus Intraoperative Interscalene Block on Postoperative Pain in Shoulder Rerverse Arthroplasty Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tear Arthropathy
Post Operative Pain
Keywords: rotator cuff arthropathy
reverse shoulder arthroplasty
supraescapular nerve radiofrecuency
post operative pain
Lead sponsor: Hospital Universitario Virgen Macarena
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial with two groups of study
Primary purpose: TREATMENT

Brief summary: The purpuse of this study is to asses if the pulsed radiofrecuency of the supraescapular nerve and accesory nerve have the same or superior efectivity controlling the acute postoperative pain than interscalenic braquial plexus block

Detailed description: This is a randomized, double-blind trial that compares the effect in postoperative pain of pulsed radiofrecuency of the supraescapular nerve carried out at least two to four weeks before reverse total shoulder arthroplasty surgery with interscalenic braquial plexus block done at the moment of the surgery. All the patients received conventional general anaesthesia and multimodal postoperative analgesia with additional patient-controlled rescue analgesics were prescribed

Eligibility criteria: Inclusion criteria:

* Over 18 y.o.
* Cronic pain (more than 3 months) due to rotator cuff arthropathy
* VAS higher than 4
* Decrease Constant score
* Conservative treatment (physiotherapy and NSAIs) unsuccessful

Exclusion criteria:

* psychiatric illness
* drug abuse.
* previous surgeries.
* acute traumatic pathology or ethiology different from rotator cuff arthropathy
* pacemaker
* infectious process

Primary outcomes:
measure: Visual analogical scale
timeFrame: periodical measurements of pain, inmediate preoperative pain up to three months postoperative
Secondary outcomes:
measure: Visual analogical scale
timeFrame: 3 months postop. until 1 year postop
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Jose Manuel Lopez Millan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01837472: Probiotics in the Treatment of Irritable Bowel Syndrome
Official title: Evaluating The Effects of Probiotics on Symptoms of Patients With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Functional gastrointestinal disorders
Gut flora
Probiotics
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 132
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: Evidence have shown benefits of gut flora modulation in treatment of irritable bowel syndrome (IBS), but few reports are available on the effects of multistrain probiotics and there are few reports available in this regard from our society. Thus, we investigated if probiotics are effective in our patients as well. We hypothesize that the multistrain probiotic Balance containing seven bacteria species including Lactobacillus strains, Bifidobacterium strains, and Streptococcus thermophiles reduces the symptoms of irritable bowel syndrome.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 65
* diagnosis of IBS based on the Rome III criteria
* willingness to participate

Exclusion Criteria:

* receiving other probiotics compound during the study
* receiving antibiotics during the study

Primary outcomes:
measure: Abdominal pain
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Department of Gastroenterology, Alzahra Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Somaye Farzamnia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brenner DM, Moeller MJ, Chey WD, Schoenfeld PS. The utility of probiotics in the treatment of irritable bowel syndrome: a systematic review. Am J Gastroenterol. 2009 Apr;104(4):1033-49; quiz 1050. doi: 10.1038/ajg.2009.25. Epub 2009 Mar 10.
Clinical trial NCT03448172: Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects
Official title: A Phase 1, Open Label, Single-period, Non-randomized Study To Evaluate The Pharmacokinetics, Excretion, Mass Balance, And Metabolism Of [14c]Pf-05221304 Administered Orally To Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-02-27
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of \[14C\]PF-05221304 in Healthy Adult Male Subjects


Eligibility criteria: Inclusion Criteria:

1. Ages of 18 and 45 years, inclusive.
2. Body mass index (BMI) of \>= 17.5 and \<= 30.4 kg/m2
3. Total body weight \> 50 kg (110 lb).

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings.

Primary outcomes:
measure: Mass Balance
timeFrame: 0-96 hr
Secondary outcomes:
measure: Metabolic profiling for PF-05221304 in plasma, urine, and feces
timeFrame: 0-96 hr
measure: Radioactivity AUClast
timeFrame: 0-96 hr
measure: Plasma PF-05221304 AUClast
timeFrame: 0-96 hr
measure: Radioactivity AUCinf
timeFrame: 0-96 hr
measure: Plasma PF-05221304 AUCinf
timeFrame: 0-96 hr
measure: Radioactivity Cmax
timeFrame: 0-96 hr
measure: Plasma PF-05221304 Cmax
timeFrame: 0-96 hr
measure: Radioactivity Tmax
timeFrame: 0-96 hr
measure: Plasma PF-05221304 Tmax
timeFrame: 0-96 hr
measure: Radioactivity t1/2
timeFrame: 0-96 hr
measure: Plasma PF-05221304 t1/2
timeFrame: 0-96 hr
measure: Number of subjects experiencing an adverse event
timeFrame: Up to 28 days post dosing of IP on Day 1
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit Inc.
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01786772: Neuromuscular Consequences of Knee Arthroscopy
Official title: Neuromuscular Consequences of Knee Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tear of Fibrocartilage of Joint
Keywords: arthroscopic partial meniscectomy
meniscus
quadriceps strength
quadriceps voluntary activation
cryotherapy
compression
vasopneumatic compression
intermittent pneumatic compression
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 39
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine changes in quadriceps muscle function following the application of ice and compression to the knee.

Detailed description: Novel rehabilitation methods, that specifically target decreased muscle activation due to joint pathology prior to strength training, have elicited greater improvements in muscle function and self-reported disability compared to traditional therapies. Preliminary evidence suggests applying cryotherapy to a joint prior to exercise can increase quadriceps activation. It is unknown if applying cryotherapy and intermittent pneumatic compression can also increase quadriceps force output and voluntary activation. The purpose of this study is to determine changes in quadriceps force output and voluntary activation following the application of cryotherapy and compression. The investigators hypothesize there will be an increase in quadriceps force output and voluntary activation following the application of cryotherapy and compression.

Eligibility criteria: Inclusion Criteria:

* Age 15-65 years
* BMI \< 30
* Candidate for arthroscopic knee surgery to address meniscus pathology or arthroscopic knee surgery within the past 2 years.

Exclusion Criteria:

* Participants who are outside of age range
* Ligamentous insufficiency or repair
* Participants with traumatic spine or lower extremity injury within past 6 months
* Participants who have had previous adverse reactions to electrical stimulation or cryotherapy (i.e. burns, hypersensitivity)
* Medical conditions which would be contraindications to electrical stimulation or transcranial magnetic stimulation, including cardiac pacemaker, metal implants in the head, current pregnancy, neurological disorders, and history of seizures
* Participants who are unable to give consent or are unable to understand procedures of experiment.

Primary outcomes:
measure: Changes in quadriceps force output and voluntary activation
timeFrame: Baseline and immediately following intervention (Single Study Visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Terry L Grindstaff, PhD, PT, ATC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03578172: HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients
Official title: Randomized, Controlled Trial to Assess the Efficacy of Human Menopausal Gonadotrophin Stimulation and Hormone Replacement Therapy for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe Intrauterine Adhesion Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Intrauterine Adhesion
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 186
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of endometrial preparation using either human menopausal gonadotrophin (HMG) stimulation and hormone replacement therapy (HRT) prior to blastocyst transfer in patients with moderate to severe intrauterine adhesion (IUA).


Eligibility criteria: Inclusion Criteria:

* BMI 18\~23 kg/m2
* Women with moderate to severe IUA as defined by the American Fertility Society classification (1988)
* Presence of at least 3 cryopreserved cleavage-stage embryos (including 1 good quality) or blastocysts

Exclusion Criteria:

* Using embryos from donor oocytes
* Preimplantation genetic diagnosis(PGD)/Preimplantation genetic screening(PGS) cycles
* Moderate or severe endometriosis
* Untreated unilateral or bilateral hydrosalpinx
* Uterine adenomyosis, uterine myoma (submucous,intramural myoma \>4 cm),\>1cm septate uterus, double uterus, bicornuate uterus, unicornuate uterus

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 10th week after embryo transfer
Secondary outcomes:
measure: Cycle cancellation rate
timeFrame: the day of embryo transfer
measure: Implantation rate
timeFrame: 4th weeks after embryo transfer
measure: Clinical pregnancy rate
timeFrame: 4th weeks after embryo transfer
measure: Early miscarriage rate
timeFrame: 12th weeks gestational age
measure: Biochemical pregnancy rate
timeFrame: 4th weeks after embryo transfer
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
References: