louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00656201: Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)
Official title: Comparison of Crinone 8% Intravaginal Gel or Intramuscular Progesterone Supplementation for In Vitro Fertilization (IVF) and Embryo Transfer (ET) Cycles in Women Under Age 40 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: Infertility
In vitro fertilization
Embryo transfer
Crinone
Intramuscular Progesterone
Progesterone support
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: EMD Serono
First posted: 2008-04-10
Enrollment: 468
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).

Detailed description: The aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing an in vitro fertilization and embryo transfer (IVF-ET) cycle are not different with respect to the administration of progesterone (Crinone 8%, intravaginal gel versus intramuscular progesterone).

Eligibility criteria: Inclusion Criteria:

* Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH \< 15 mIU/ml
* Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG.

Exclusion Criteria:

* Women who have had more than 3 previous IVF/ET cycles

Primary outcomes:
measure: Percentage of Pregnant Patients After IVF Treatments
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Elena H Yanushpolsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yanushpolsky E, Hurwitz S, Greenberg L, Racowsky C, Hornstein M. Crinone vaginal gel is equally effective and better tolerated than intramuscular progesterone for luteal phase support in in vitro fertilization-embryo transfer cycles: a prospective randomized study. Fertil Steril. 2010 Dec;94(7):2596-9. doi: 10.1016/j.fertnstert.2010.02.033. Epub 2010 Mar 27.
Clinical trial NCT04136301: The Effect of Exposure to an Informative Video on Maternal Anxiety
Official title: The Effect of Exposure to an Informative Video Regarding Possible Obstetric Emergencies on Maternal Anxiety and Peripartum Satisfaction- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Labor Pain
Patient Satisfaction
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-10-23
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Stress and anxiety during childbirth have negative consequence on both mother and fetus. Previous studies have learned the effect of several intervention to reduce anxiety during labor- such as music and foot reflexology. Nevertheless, data for informative video before labor for reducing stress and anxiety are sparse. The present study aimed to review and determine the effect of informative video on anxiety, pain and outcomes of the labor in primigravida women.

Detailed description: A randomized control trial studying the effect of exposure to an informative video regarding labor and possible obstetrics emergencies on maternal anxiety and postpartum satisfaction

Eligibility criteria: Inclusion Criteria:

above 18 years of age Nulliparus women Informed consent Reads and understand Hebrew \>37 weeks of gestation

Exclusion Criteria:

Refuse to participate Contraindications for vaginal delivery

Primary outcomes:
measure: The State-Trait Anxiety Inventory score in delivery room
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Wolfson medical center
Study officials:
References:
Clinical trial NCT02376101: Minimal Occlusive Pressure With Cuffed ETT: the Effect of Size on Intracuff Pressure
Official title: Minimal Occlusive Pressure With Cuffed ETT: the Effect of Size on Intracuff Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracuff Pressure
ETT Size
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this current study is to evaluate whether the size of the endotracheal tube (ETT) that is used impacts the intracuff pressure that occurs when the airway is sealed. If there is excessive pressure in the cuff of a smaller ETT when it is inflated, there may be inherent risks associated with the use of a cuffed endotracheal tube that is less than the appropriate size. The investigators believe that the size of the tube chosen has an impact on the characteristics of the inflated cuff and hence the intracuff pressure and the sealing pressure are variable.


Eligibility criteria: Inclusion Criteria:

* Patients requiring intubation with an ETT for a surgical procedure.
* Children ages 4 to 8 years old.
* Surgical procedure lasting less than 60 minutes.

Exclusion Criteria:

* Patients undergoing a surgical procedure that is anticipated to last longer than 60 minutes.
* Patients that are known or anticipated to have a difficult airway.

Primary outcomes:
measure: Intracuff pressure
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00617201: Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
Official title: Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Abuse
Keywords: cocaine
dependence
stimulants
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: National Institute on Drug Abuse (NIDA)
First posted: 2008-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.


Eligibility criteria: Inclusion Criteria:

* Seeking treatment for cocaine dependence
* Must have used cocaine in the past 30 days

Exclusion Criteria:

* Physical dependence on any drug requiring medical management
* Any major medical or psychiatric disorder that would be contraindicated for participation
* Cardiovascular disease
* Seizures or significant head injuries
* Currently taking atomoxetine
* Pregnant or breast-feeding

Primary outcomes:
measure: % Urine Samples Negative for Cocaine
timeFrame: Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks
Secondary outcomes:
measure: Retention
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Straus Research Building
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Sharon L Walsh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03124901: Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the concentration of hemoglobin within the subject's blood is affected by fluid status changes. The fluid status is affected by fluid loss during surgery for hospitalized study subjects or controlled administration of fluids intravenously for healthy study volunteers. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparing with blood sample analysis.


Eligibility criteria: Inclusion Criteria:

* Has physical status between ASA 1 or 2
* Able to communicate in English

Exclusion Criteria:

* Pregnant or sexually active without birth control.
* Hemoglobin less than 11g/dL
* Known alcohol or drug abuse
* Skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection
* Nail polish
* Head injury with loss of consciousness within the last year
* Known neurological and psychiatric conditions.
* Known concurrent chronic usage of psychoactive or anti-convulsive drugs within the last 90 days, or use in the last 7 days (i.e. tricyclic antidepressants, MAO inhibitors, lithium, neuroleptics, anxiolytics or antipsychotics. Except SSRIs
* Subject has any medical condition which, in the judgement of the investigator, renders them inappropriate for participation in this study, such as Reynods syndrome
* Hypertension: Systolic BP \>= 140 mmHg or Diastolic BP \>= 90 mmHg
* Baseline heart rate \<50 beats per minute

Primary outcomes:
measure: Accuracy of Sensor
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
References:
Clinical trial NCT02126501: Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants
Official title: Randomized Control Trial of Weaning NCPAP From Preterm Infants: Sudden Wean Versus Weaning by Gradually Decreasing Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: weaning
NCPAP
Preterm
sudden wean
gradual pressure off wean
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 70
Sex: ALL
Minimum age (years): 26
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in premature babies born between 26 and 32 weeks

Detailed description: To study the weight and the post menstrual age (PMA) at the time of NCPAP wean utilizing the method of sudden wean as compared to gradual wean.

Methods: A prospective randomized trial was conducted comparing sudden weaning with gradual weaning from NCPAP in neonates with gestational age between 26 and 32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared

Eligibility criteria: Inclusion Criteria:

* All neonates born 26 to 32 weeks of gestational age

Exclusion Criteria:

* Those with severe congenital anomalies and chromosomal defects including congenital heart disease, neurological malformations, chest and airway abnormalities and lung hypoplasia

Primary outcomes:
measure: Success of weaning on first trial off NCPAP
timeFrame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
Secondary outcomes:
measure: Weight and corrected GA when come off oxygen
timeFrame: when off supplemental oxygen expected average of 2 weeks
measure: Weight and corrected gestational age (GA) when neonates could come off NCPAP
timeFrame: Completion of Nasal Continuous Positive Airway Pressure (NCPAP) treatment, expected average of 4 weeks
Other outcomes:
measure: length of stay in the neonatal intensive care unit
timeFrame: when ready to be discharged, expected average of 6-8 weeks
Locations:
city: Brooklyn
country: United States
facility: Maimonides medcial center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Shantanu Rastogi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amatya S, Macomber M, Bhutada A, Rastogi D, Rastogi S. Sudden versus gradual pressure wean from Nasal CPAP in preterm infants: a randomized controlled trial. J Perinatol. 2017 Jun;37(6):662-667. doi: 10.1038/jp.2017.10. Epub 2017 Feb 23.
Clinical trial NCT04333004: Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy
Official title: Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Gut Microbiota
NSCLC
Pembrolizumab
Chemotherapy
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Analysis of Gut Microbiota in Patients With Brain Metastasis of Non-small Cell Lung Cancer Treated by Pembrolizumab Combined With Chemotherapy


Eligibility criteria: Inclusion Criteria:

- non-small cell lung cancer patients with less than brain metastases Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment Patients who have not received intracranial local treatment before

Exclusion Criteria:

- Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds Patients with hemorrhage in intracranial metastasis

Primary outcomes:
measure: diversity of gut microbiota
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03811704: Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging
Official title: Real-time Navigation for Laparoscope Liver Resections Using Fusion 3D Imaging and Indocyanine Green Fluorescence Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Resection
Keywords: three-dimensional reconstruction
fluorescence
indocyanine green
liver resection
navigation surgery
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the feasibility and efficacy of a novel real-time navigation way for laparoscope liver resection, which was fused images comprising 3D imaging and indocyanine green Fluorescence imaging (fusion IGFI).

Detailed description: During liver resection, surgeons cannot completely view the intraparenchymal structure. Although a fluorescent imaging technique using indocyanine green has recently been developed for hepatobiliary surgery, limitations in its application for real-time navigation persist. A nove augmented reality surgery navigation system (ARSNS) can be combined with indocyanine green Fluorescence imaging to guide the surgery real-time.

Eligibility criteria: Inclusion Criteria:

1. 18 years≤ Age ≤70 years
2. Compling with the diagnosis criteria of complex hepatic carcinoma.
3. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled
4. Preoperative liver function is Child - Pugh grade A or B.
5. The patients are volunteered for the study.

Exclusion Criteria:

1. Patients with mental illness.
2. Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc.)
3. The patients refused to take part in the study.
4. There are other co-existed malignant tumors.
5. Benign liver diseases.
6. Indocyanine green allergy

Primary outcomes:
measure: Liver resection navigation success rate
timeFrame: intraoperative
Secondary outcomes:
measure: Postoperative complication rate
timeFrame: 3 months
measure: Operative outcomes
timeFrame: intraoperative
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: China, Guangdong Zhujiang Hospital of The Southern Medical University
name: Chihua Fang, M.D.;Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01908504: Adaptive Pet Study
Official title: F Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) for the Delivery of Adaptive Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancers
Lung and Esophagus Cancers
Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the benefit of using positron emission tomography (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for cancer treatment. The information from the PET-CT may allow the investigators to change the radiation plan or the delivery of the radiation to the tumor/tumor site such as the total dose of radiation or the size of the area to receive further radiation. Presently the use of PET scans to adjust radiation therapy during radiation treatment is not standard of care and is being investigated in this study.


Eligibility criteria: Inclusion Criteria:

* Pathologically (histologically or cytologically) proven diagnosis of carcinoma
* Patients with local or regional nodal disease are eligible.
* Zubrod Performance Status 0, 1, or 2.
* Age ≥ 18
* Negative serum pregnancy test for women of child bearing potential
* Patient must sign study-specific informed consent prior to study entry.

Exclusion Criteria:

* No gross disease visible on imaging at the start of radiotherapy
* Contraindication to PET
* Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy)
* Breast feeding

Primary outcomes:
measure: The number of subjects with benefit from an intra-treatment PET-CT
timeFrame: 3 years
Secondary outcomes:
measure: Locoregional control.
timeFrame: Day of intra treatment PET-CT/ approx 2-4 hours
measure: Freedom from distant metastases
timeFrame: 3 years
measure: Measure overall survival (OS)
timeFrame: 3 years
measure: Measure acute toxicities
timeFrame: During radiation therapy and within 30 days of the last radiation treatment
measure: Measure late toxicities
timeFrame: 3 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Junzo Chino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mowery YM, Vergalasova I, Rushing CN, Choudhury KR, Niedzwiecki D, Wu Q, Yoo DS, Das S, Wong TZ, Brizel DM. Early 18F-FDG-PET Response During Radiation Therapy for HPV-Related Oropharyngeal Cancer May Predict Disease Recurrence. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):969-976. doi: 10.1016/j.ijrobp.2020.08.029. Epub 2020 Aug 13.
Clinical trial NCT06251804: Effectiveness of Short-Foot Exercises in Water and on Land in Pes Planus
Official title: Effectiveness of Short-Foot Exercises in Water and on Land in Pes Planus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pes Planus
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pes planus is caused by the elongation of the intrinsic muscles in the medial arch of the foot, causing the arch to approach the ground or the sole of the foot to touch the ground completely.

Detailed description: For this purpose, in this project, the effectiveness of short foot exercises in water and on land will be compared in young adults with pes planus.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-25
* Having bilateral pes planus
* People with a score of 6 and above on the Foot Posture Index Score
* Individuals with more than 10 millimeters of pronation according to the navicular drop test were included.

Exclusion Criteria:

* Rigid pes planus, hallux valgus, hallux rigidus, epin calcanei
* Lower extremity surgery
* Neurological or orthopedic problems and history of disease
* Regular exercise for the treatment of pes planus in the last three months

Primary outcomes:
measure: Foot Posture Index
timeFrame: 6 weeks
measure: Navicular Drop Test
timeFrame: 6 weeks
measure: Biodex Balance System
timeFrame: 6 weeks
Secondary outcomes:
measure: Pittsburg Sleep Index
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahçehir University
Study officials:
References: