louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02801591: Effect of Recombinant Human Growth Hormone Injection on the Clinical Outcome of POR in Patients Undergoing IVF/ET
Official title: Effect of Recombinant Human Growth Hormone Injection on the Clinical Outcome of Poor Ovarian Response (POR) Clinical Outcome in Patients Undergoing in Vitro Fertilization / Embryo Transfer (IVF/ET)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Poor Ovarian Response
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University Third Hospital
name: Peking University People's Hospital
First posted: 2016-06-16
Enrollment: 240
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Poor ovarian response

Brief summary: Observe the clinical efficacy and safety of Recombinant Human Growth Hormone Injection assisted in the treatment of the patients with poor ovarian response in vitro fertilization and embryo transfer.


Eligibility criteria: Inclusion Criteria:

* Female, age 30-42 years old.
* Diagnosis of POR (2011 ESHRE Bologna Standard).
* At least two previous IVF failure history.
* Voluntarily to sign the "informed consent".

Exclusion Criteria:

* Severe acute and chronic liver and kidney disease，Such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity period, etc.；Liver and kidney dysfunction.
* Endocrine and metabolic diseases，eg, diabetes、Thyroid function hyperthyroidism, Thyroid dysfunction, cushing's syndrome, hyperprolactinemia，hyperandrogenism.
* Related diseases affecting outcome of IVF pregnancy，eg, hydrosalpinx, hysteromyoma≥4cm, adenomyosis, stage III and IV endometriosis, untreated endometrial lesions, uterine malformation, genital tuberculosis, malignant tumor of reproductive system （include endometrial carcinoma, cervical carcinoma, ovarian cancer, fallopian tube carcinoma）.
* Allergic to E. coli expression product and its excipients.
* Subjects who participated in the past three months or are participating in other drug clinical researchers.
* IVF failure history≥3.
* The researchers consider who is not suitable for enrolling the group.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: One year
Secondary outcomes:
measure: Number of retrieved oocytes
timeFrame: One year
measure: Number of high quality embryos
timeFrame: One year
measure: Number of embryos transferred
timeFrame: One year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: People's Hospital of Peking University
Study officials:
affiliation: Peking University Third Hospital
name: Xin Na Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01950091: Internet App to Self-Manage Occasional Low Back Pain
Official title: Randomized Controlled Trial of Internet App to Self-Manage Occasional Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
internet
app
prevention
treatment
Lead sponsor: Oregon Center for Applied Science, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2013-09-25
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Nonspecific low back pain (NLBP) is the diagnosis for 85% of low back pain sufferers with no underlying medical cause (e.g., herniated disc, spinal stenosis) that requires physician care. Treatment, however, is impractical for many physicians to implement during office visits, and there are relatively few providers for NLBP treatment that follow national pain control guidelines. This study evaluated the efficacy of an on-line intervention using desktop computers or mobile technology to help users self treat NLBP occurrences and to engage in activities to decrease future occurences.

Detailed description: Methods. A total of 606 adults, 18 years of age and older were recruited, screened, and consented online. They were assessed on-line at baseline, at two months weeks, and at four months After the baseline assessments, participants were randomized into NLBP treatment (TX), alternative website control (AWC), and no-contact control groups. The TX and AWC groups received 8 weekly emails prompt to visit their respective experimental websites.

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Eligibility criteria: Inclusion Criteria:

* suffered low back pain in previous 3 months
* employed or family of employee

Exclusion Criteria:

* on-going medical care for low back pain
* positive response to questions about symptoms which medically disqualify potential participant

Primary outcomes:
measure: Change in responses to the Modified Oswestry Low Back Pain Disability Questionnaire
timeFrame: Baseline, 2 months, 4 months
Secondary outcomes:
measure: Change in responses to psycho-social measures (attitudes, knowledge, self efficacy, intentions); self treatment measures
timeFrame: baseline, 2 and 4 months
Other outcomes:
Locations:
Study officials:
affiliation: ORCAS Research Scientist
name: Blair Irvine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Irvine AB, Russell H, Manocchia M, Mino DE, Cox Glassen T, Morgan R, Gau JM, Birney AJ, Ary DV. Mobile-Web app to self-manage low back pain: randomized controlled trial. J Med Internet Res. 2015 Jan 2;17(1):e1. doi: 10.2196/jmir.3130.
Clinical trial NCT02717091: Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
Official title: Phase II Study of Neoadjuvant FOLFIRINOX or Nab-paclitaxel With Gemcitabine for Borderline Resectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Borderline Resectable Pancreatic Cancer
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to clarify the efficacy and safety of neoadjuvant FOLFIRINOX and nab-paclitaxel + gemcitabine for borderline resectable pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

1. Borderline resectable pancreatic cancer (based on NCCN guideline version 2.2015)
2. first treatment for pancreatic cancer
3. performance status 0 or 1
4. adequate one marrow function
5. adequate renal function
6. obtained informed consent

Exclusion Criteria:

1. other active concomitant malignancies
2. other severe medical conditions; contraindication of FOLFIRINOX, paclitaxel and gemcitabine
3. pregnant women
4. no informed consent

Primary outcomes:
measure: R0 resection rate
timeFrame: 3 months
Secondary outcomes:
measure: completion rate of chemotherapy
timeFrame: 3 months
measure: relative dose intensity
timeFrame: 3 months
measure: adverse event
timeFrame: 3 months
measure: tumor response
timeFrame: 3 months
measure: disease free survival
timeFrame: 3 years after the surgery
measure: overall survival
timeFrame: 3 years after the surgery
measure: surgical complication
timeFrame: 1 month after the surgery
measure: quality of the tumor
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00244491: The Care Transitions Intervention
Official title: The Care Transitions Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Continuity of Patient Care
Keywords: care transitions
geriatric
care coordination
self-management
chronic illness
patient-centered care
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: The John A. Hartford Foundation
First posted: 2005-10-26
Enrollment: 1400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This intervention tests whether encouraging older patients and their caregivers to assert a more active role in their care transitions could improve clinical outcomes. Patients are supported by a nurse transition coach and specific tools, including a Personal Health Record.

Detailed description: See above.

Eligibility criteria: Inclusion Criteria:

* To be eligible for this study, patients from the participating delivery system had to: 1) be age 65 years or older, 2) be admitted to one of the participating delivery system's contract hospitals during the study period for a non-psychiatrically-related condition, 3) be community-dwelling (i.e., not from a long-term care facility), 4) reside within a predefined geographic radius of the hospital (thereby making a home visit feasible), 5) have a working telephone, 6) be English-speaking, 7) show no documentation of dementia in the medical record, 8) have no plans to enter hospice, 9) not be participating in another research protocol, and 10) have documented in their medical record at least one of 11 diagnoses, including stroke, congestive heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, diabetes, spinal stenosis, hip fracture, peripheral vascular disease, deep venous thrombosis, or pulmonary embolism.

Exclusion Criteria:

* Those who did not meet the inclusion criteria.

Primary outcomes:
measure: Rehospitalization rate at 30, 90 and 180 days after index hospitalization.
Secondary outcomes:
measure: Rehospitalization rate at 30, 90 and 180 days after index hospitalization. Rehospitalization for the same condition as the index hospital stay, at 30, 90 and 180 days.
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Eric A. Coleman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coleman EA, Parry C, Chalmers S, Min SJ. The care transitions intervention: results of a randomized controlled trial. Arch Intern Med. 2006 Sep 25;166(17):1822-8. doi: 10.1001/archinte.166.17.1822.
Clinical trial NCT02048891: Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2014-01-29
Enrollment: 3
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given.

The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.


Eligibility criteria: Inclusion Criteria:

* IVF patients with at least 4 consecutive failures.
* On trigger day, no more than 10 follicles of 12 mm and up

Exclusion Criteria:

* History of moderate or severe OHSS.

Primary outcomes:
measure: Fetal Heart Activity 1 Month After Oocyte Retrieval
timeFrame: 1 month after oocyte retrieval
Secondary outcomes:
measure: Patients Comfort During the Luteal Phase
timeFrame: During 2 weeks from day of oocyte retrieval
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: IVF Unit, Rambam medical Center
Study officials:
References:
Clinical trial NCT05967091: Ryme Medical TLD Pilot Study
Official title: Targeted Lung Denervation (TLD) With the Ryme Medical Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Ryme Medical TLD Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Dyspnea
Lung denervation
Bronchoscopic intervention
Lung disease
Lung diseases, obstructive
Respiratory tract diseases
Lead sponsor: Ryme Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, non-randomized
Primary purpose: TREATMENT

Brief summary: Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study

Detailed description: The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD)

Eligibility criteria: Key Inclusion Criteria:

* Symptomatic chronic obstructive pulmonary disease
* ≥40 years of age
* Smoking history of at least 10 pack years
* Candidate for bronchoscopy in the opinion of the Investigator

Key Exclusion Criteria:

* Recent COPD exacerbation or respiratory infection
* Prior lung intervention with device in place
* Pulmonary nodule or malignancy requiring treatment
* Current chemotherapy or radiation therapy and/or has received treatment within 6 months
* Current smoker, using e-cigarettes or vaping, or taking any inhaled substances not prescribed by a physician
* Clinically significant serious or unstable medical conditions (e.g., heart disease requiring treatment, uncontrolled diabetes)
* Pregnant, nursing, or intent to become pregnant during study duration

Primary outcomes:
measure: Device Safety
timeFrame: 30 Days
Secondary outcomes:
measure: Device Success
timeFrame: Day 0
measure: Technical Success
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06041191: Sensory Processing Skills in Toddler With Joint Hypermobility
Official title: An Investigation of Sensory Processing Skills in Toddler With Joint Hypermobility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development
Sensory Disorder
Hypermobility, Joint
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children born at term between 12-14 months

Brief summary: shows that children and adults with joint hypermobility may be identified with common clinical problems that are unrelated, such as chronic fatigue, anxiety, and a range of gastrointestinal functional disorders \[4-6\]. Considering the relationship of joint hypermobility with joint muscle tone and posture, sensory processing skills may also be affected in individuals with hypermobility. No study in the literature examines the relationship between joint hypermobility and sensory processing. This study was planned to detect joint hypermobility as early as 12-14 months and to examine its relationship with sensory processing skills.


Eligibility criteria: Inclusion Criteria:

12-14 month old healthy children

-

Exclusion Criteria:

* they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.

Primary outcomes:
measure: Beighton Score
timeFrame: 20minutes
Secondary outcomes:
measure: Test of Sensory Functions in Infants
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Erzurum Technical University
Study officials:
References:
Clinical trial NCT05070091: The Impact of Pituitary-thyroid and Pituitary-adrenal Axes Function on COVID-19 Clinical Course.
Official title: The Impact of Pituitary-thyroid and Pituitary-adrenal Axes Function on COVID-19 Clinical Course.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Low Triiodothyronine Syndrome
Adrenal Insufficiency
Subacute Thyroiditis
Hypothyroidism
Hyperthyroidism
Keywords: COVID-19, thyroid, adrenal gland, pituitary, glucocorticoids
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
Collaborators: name: National Center for Research and Development, Poland
First posted: 2021-10-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients with PCR-confirmed COVID-19 infection.

Brief summary: The main focus of the study is the assessment of hormonal function in the course of COVID-19 infection with special regard for trends predicting clinical events defined as primary endpoints of the study.


Eligibility criteria: Inclusion Criteria:

* PCR-confirmed COVID-19 infection
* volunteers consenting to participate

Exclusion Criteria:

* no consent

Primary outcomes:
measure: Meeting the primary endpoint criteria.
timeFrame: Time of hospitalization, typically less than one month.
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: 7 Szpital Marynarki Wojennej
city: Gdańsk
country: Poland
facility: Medical University of Gdansk
Study officials:
affiliation: Medical University of Gdansk
name: Renata Świątkowska-Stodulska, MD PhD
role: STUDY_DIRECTOR
affiliation: Medical University of Gdansk
name: Agata Berlińska, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753791: Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of PF-06473871 In Normal Healthy Adults
Official title: A Phase 1, Dose Expansion Of A Within-cohort, Randomized, Double-blind, Third-party Open, Placebo-controlled, Single-and Multiple-dose Escalation Study To Evaluate Safety, Tolerability, And Pharmacokinetics Of Pf-06473871 In Normal Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or females between the ages of 18 and 55 years inclusive

Exclusion Criteria:

* Currently pregnant

Primary outcomes:
measure: Incidence of Adverse events
timeFrame: 6 weeks
measure: ECGs
timeFrame: 6 weeks
measure: Blood pressure
timeFrame: 6 weeks
measure: pulse rate
timeFrame: 6 weeks
measure: Injection siter reaction
timeFrame: 6 weeks
measure: number of subjects with adverse events
timeFrame: 6 weeks
measure: severity of adverse events
timeFrame: 6 weeks
Secondary outcomes:
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 6 weeks
measure: Area under the Concentration-Time Curve (AUC)
timeFrame: 6 weeks
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00705991: Validation of Thrombelastometry (ROTEM®)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-06-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Patients

Brief summary: Das Hauptziele der Studie ist das ROTEM® zu validieren durch die Untersuchung von:

i) Reproduzierbarkeit von ROTEM® ii) Präzision der ROTEM®-Tests, sowie iii) der Zeitspanne, während derer die Ergebnisse in Zitrat-Blut reproduzierbar sind

Die durchzuführenden Tests sind FIBTEM, EXTEM, INTEM in ROTEM® um die Funktion der Thrombozyten während der Lagerungszeit zu untersuchen.

Nur Zitrat-Blut wird den Patienten abgenommen, die Reklazifikation findet kurz vor der Durchführen der Tests stattfinden, um so nahe wie möglich an der klinischen Praxis zu sein.


Eligibility criteria: Inclusion criteria: 1. Vorgesehen für einen elektiven Eingriff 2. Unterschriebene Einverständniserklärung

Exclusion criteria: 1. bekannte Tumorerkrankung oder Immunosupression, 2. bekannte Gerinnungsstörung 3. Antikoagulation 4. Behandlung mit Heparin über 3000 UI im Sinne der Thrombose-Prophylaxe hinaus 5. Gebrauch von Acetylsalicylsäure innerhalb der letzten 5 Tage 6. Gebrauch von NSRA innerhalb der letzten 24 Stunden 7. bekannte Niereninsuffizienz oder eine Plasmakonzentration von Kreatinin grösser 120 Mm, oder Lebererkrankungen oder einer Plasmakonzentration von ASAT (\> 50 U/l) oder ALAT (\> 50 U/l).

8. Patienten / Patientinnen und Probanden / Probandinnen die der Deutschen Sprache nicht mächtig sind.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: University Hospital Zurich, Division of Anaesthesiology
name: Donat R Spahn, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: