louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04559100: Long-term Characterization of Patients With Severe/Critical Infection by COVID-19 Virus
Official title: Clinical, Radiological, Lung Function, and Quality of Life Characterization of Patients With Severe/Critical Infection by SARS-COV-2 (COVID-19) Virus, After 6 and 12 Months of Hospital Discharge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: covid19
lung function
quality of life
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a severe or critical disease caused by SARS-COV-2 infection who were treated at the ICU of Fundación Valle del Lili and were alive at 6 months of hospital discharge.

Brief summary: A descriptive study to characterize clinical, radiological, lung function and quality of life alterations in patients who survived a severe or critical disease caused by SARS-COV-2 virus, who were treated in the intensive care unit of a high complexity institution in Cali, Colombia.


Eligibility criteria: Inclusion Criteria:

* ≥ 19 years old who had a positive test for SARS-COV-2 virus
* Patients with a severe and critical disease by SARS-COV-2, who were treated at the ICU of Fundación Valle del Lili, and survived
* Patients with chest radiography or CT scan at admission to the hospital

Exclusion Criteria:

* Patients who do not sign informed consent.

Primary outcomes:
measure: Lung function
timeFrame: 6 months after hospital discharge
measure: Lung function
timeFrame: 12 months after hospital discharge
measure: Lung function
timeFrame: 6 months after hospital discharge
measure: Lung function
timeFrame: 12 months after hospital discharge
measure: Lung function
timeFrame: 6 months after hospital discharge
measure: Lung function
timeFrame: 12 months after hospital discharge
measure: Radiological alterations
timeFrame: 6 months after hospital discharge
measure: Radiological alterations
timeFrame: 12 months after hospital discharge
measure: Radiological alterations
timeFrame: 6 months after hospital discharge
measure: Radiological alterations
timeFrame: 12 months after hospital discharge
measure: Quality of life alterations
timeFrame: 6 months after hospital discharge
measure: Quality of life alterations
timeFrame: 12 months after hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundacion Valle del Lili
state: Valle Del Cauca
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Fernandez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750100: Low Dose hCG in the Late Follicular Phase
Official title: Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: infertility
IVF
hCG
primary infertility
secondary infertility
patients requiring in-vitro fertilisation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2008-09-10
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.


Eligibility criteria: Inclusion Criteria:

* \< 36 years on day of randomisation
* FSH \< 12 in the early follicular phase
* Normal ultrasound scan
* BMI between 18 and 29 (both inclusive)
* Randomisation at outpatient clinic

Exclusion Criteria:

* Endometriosis ≥ grade 3
* PCO syndrome
* Poor responder
* Endocrine or metabolic abnormalities

Primary outcomes:
measure: Number of oocytes in both treatment groups
timeFrame: up to 9 months
Secondary outcomes:
measure: Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Laarbeeklaan 101
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
affiliation: UZ Brussel, Centre for Reproductive Medicine, Brussels
name: Christophe Blockeel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401. doi: 10.1016/j.fertnstert.2005.02.036.
citation: Blockeel C, De Vos M, Verpoest W, Stoop D, Haentjens P, Devroey P. Can 200 IU of hCG replace recombinant FSH in the late follicular phase in a GnRH-antagonist cycle? A pilot study. Hum Reprod. 2009 Nov;24(11):2910-6. doi: 10.1093/humrep/dep253. Epub 2009 Jul 17.
Clinical trial NCT01842100: To Compare the Strategies of Universal Antibiotic Prophylaxis Versus Screen-and-treat in Reducing Infective Complications and Re-infection in Women Who Undergo Termination of Pregnancy
Official title: To Compare the Strategies of Universal Antibiotic Prophylaxis Versus Screen-and-treat in Reducing Infective Complications and Re-infection in Women Who Undergo Termination of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced Abortion
Postaboral Pelvic Inflammatory Disease
Sexually Transmitted Infections
Keywords: Induced abortion
Postaboral pelvic inflammatory disease
Sexually transmitted infections
Universal antibiotic prophylaxis
Screen-and-treat approach
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2013-04-29
Enrollment: 2193
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Screen-and-treat approach reduces postabortal pelvic inflammatory disease after induced abortion, and at the same time alters women's sexual behavior and prevents further re-infection by sexually transmitted infections when compared to the universal antibiotic prophylaxis strategy.

Detailed description: While universal antibiotic prophylaxis during induced abortion has been proven to reduce postabortal pelvic inflammatory diseases, screen-and-treat approach has the potential benefit of altering women's sexual behavior and preventing further re-infection by sexually transmitted infections. We conducted a randomized controlled trial to compare the effect of the two approaches in preventing postabortal pelvic inflammatory disease and the women's sexual behavior.

Eligibility criteria: Inclusion Criteria:

* women requesting for induced abortion in the gynecology clinic

Exclusion Criteria:

* nil

Primary outcomes:
measure: Rate of postabortal inflammatory disease 6 weeks after induced abortion.
timeFrame: 6 weeks after induced abortion.
Secondary outcomes:
measure: Rate of re-infection by sexually transmitted infections 24 weeks after induced abortion.
timeFrame: 24 weeks after induced abortion.
measure: Proportion of women having abstinence from sexual intercourse or using condom at 6 weeks, 24 weeks and 1 year after induced abortion.
timeFrame: 6 weeks, 24 weeks and 1 year after induced abortion
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
state: Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Sofie SF Yung, MBBS, MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01219400: Vildagliptin and the Glucagon Response to Hypoglycemia in Insulin-Treated Patients With Type 2 Diabetes
Official title: Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Insulin-treated Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Keywords: DPP-4
GLP-1
Glucagon
Catecholamines
Counterregulation
Insulin-treatment
Type 2 diabetes
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to explore whether the novel therapy of type 2 diabetes, vildagliptin, which inhibits dipeptidyl peptidase-4 (DPP-4), affects glucagon counterregulation during hypoglycemia in insulin-treated patients with type 2 diabetes. Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment.

Detailed description: Vildagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) and inhibits glucagon secretion and stimulates insulin secretion. This improves glycemia in subjects with type 2 diabetes with a very low risk for hypoglycemia. If hypoglycemia nevertheless develops, it is important that vildagliptin under such conditions does not inhibit glucagon secretion, since that would aggravate the hypoglycemia. It was indeed previously demonstrated in type 2 diabetes that vildagliptin dos not inhibit glucagon secretion during hypoglycemia. This study explores whether vildagliptin affects glucagon counterregulation during hypoglycemia in insulin-treated patients of type 2 diabetes. Vildagliptin is given, together with the on-going insulin therapy, for one month, whereafter hypoglycemia is induced under standardized conditions, and the glucagon response is determined, and compared to that after a month of placebo treatment. The hypoglycemia is induced bvy a standardized clamp procedure.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Insulin treatment
* Age \>18 years
* HbA1c \<=8.5%

Exclusion Criteria:

* Pregnancy
* Lactation
* Acute infection
* Liver disease
* Treatment with cortisol

Primary outcomes:
measure: Glucagon response to hypoglycemia
timeFrame: 45 min
Secondary outcomes:
measure: Catecholamine response to hypoglycemia
timeFrame: 45 min
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Lund University
name: Bo Ahrén, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05343000: Lifestyle Program for Obstructive Sleep Apnea with Severe Obesity
Official title: A Lifestyle Program for Severe Comorbid Obstructive Sleep Apnea with Severe Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Minnesota HealthSolutions
First posted: 2022-04-25
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop a data driven system for persons with severe obesity sleep apnea that utilizes remote monitoring with health coaching to create behavior changes aimed at improving health and quality of life.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18 years of age or older.
* Newly diagnosed with severe Obstructive Sleep Apnea (OSA) and severe obesity (BMI \> 35).

Exclusion Criteria:

* Individuals \< 18 years of age.
* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Primary outcomes:
measure: Feasibility of proposed system in patients with OSA and Obesity
timeFrame: Qualitative Interviews will be completed at the end of the two week trial
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto Benzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06840600: Public Support for Prison Nutrition Standards
Official title: Public Support for Prison Nutrition Standards
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2025-02-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this experiment is to examine the impact of policy rationale on public support for prison nutrition standards. The main question this experiment aims to answer is:

Does the rationale provided for a policy to improve prison nutrition standards impact public support for such a policy?

Additionally, this experiment aims to answer:

To what extent are participant demographic characteristics correlated with public support for prison nutrition standards?

Detailed description: This study aims to examine the impact of policy rationale on public support for prison nutrition standards. In an online survey, participants will be asked to imagine a new U.S. policy which would require prisons to serve meals that meet the government definition of healthy. Participants will then be randomly assigned to view 1 of 3 different rationales for the new policy, or be assigned to a control arm where no rationale is given. All participants will answer a question about support for the policy.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Report residing in the US
* Can read and speak English
* Have internet access to complete the online survey

Exclusion Criteria:

* Under 18 years of age
* Residing outside the US

Primary outcomes:
measure: Policy Support
timeFrame: Assessed one-time via online survey immediately after participant views each policy rationale (exposure to study stimuli). Overall survey will take approximately 15 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carolyn Chelius, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00721500: A Comparison of Two Daily Disposable Contact Lenses.
Official title: An Evaluation of the Lens Fit of Narafilcon A Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2008-07-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.


Eligibility criteria: Inclusion Criteria:

* They are of legal age (18 years) and capacity to volunteer.
* They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
* They are willing and able to follow the protocol.
* They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
* They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
* They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
* They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

* They have an ocular disorder which would normally contra-indicate contact lens wear.
* They have a systemic disorder which would normally contra-indicate contact lens wear.
* They are using any topical medication such as eye drops or ointment.
* They are aphakic.
* They have had corneal refractive surgery.
* They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
* They are pregnant or lactating.
* They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
* They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
* They have diabetes.
* They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Primary outcomes:
measure: Proportion of Eyes Successfully Fit
timeFrame: Within 20 minutes of lens insertion
measure: Lens Fit Decentration
timeFrame: Within 20 minutes of lens insertion
measure: Lens Tightness on Cornea With Manual Digit Push Up
timeFrame: Within 20 minutes of lens insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Farnham
country: United Kingdom
facility: Visioncare Research Ltd
state: Surrey
Study officials:
References:
Clinical trial NCT04553900: Effect of Heat Stress on Global LV Function in Anesthetized Humans
Official title: Effect of Heat Stress on Global LV Function in Anesthetized Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperthermia
Cardiac Functional Disturbances During Surgery
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recent data suggests that increased temperature improves inotropic function during systole and may improve diastolic function in healthy humans at rest, despite a reduction in left ventricular volume at end diastole. The effect of heat stress has not been reported in patients receiving general anesthesia and the impact of general anesthesia on these findings is not known. Trans-esophageal echocardiography will be used to measure parameters important to both systolic and diastolic function at temperature intervals of 1°C in patients undergoing "Heated Intraoperative Peritoneal Chemotherapy" (HIPEC.) That general anesthesia will not alter the cardiovascular effects of increased temperature that has been reported in healthy, un-anesthetized humans is the hypothesis.


Eligibility criteria: Inclusion Criteria:

* any patient presenting for hyperthermic intraperitoneal chemotherapy.

Exclusion Criteria:

* Subjects less than 18 years old.
* pregnant women
* prisoners,
* institutionalized individuals
* Any patient with known contraindication to Transesophageal echocardiography.
* Patients with known cardiac dysfunction prior to screening will be excluded.

Primary outcomes:
measure: Change in ejection fraction before and after hyperthermia
timeFrame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Secondary outcomes:
measure: Transmitral inflow velocities before and after hyperthermia
timeFrame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
measure: Pulmonary venous inflow velocities before and during hyperthermia
timeFrame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
measure: Mitral annular tissue doppler velocities before and during hyperthermia
timeFrame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Other outcomes:
measure: heart rate before and during hyperthermia
timeFrame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
measure: mean arterial pressure before and during hyperthermia
timeFrame: Approximately 6 hours from prior to hyperthermia to during hyperthermia.
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Edward O O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01435200: Intravenous Iron in Gynecologic Cancer Patients Receiving Chemotherapy
Official title: Prevention of Blood Transfusion With Intravenous Iron in Gynecologic Cancer Patients Receiving Platinum Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gynecologic Cancer
Keywords: Intravenous iron
gynecologic cancer blood transfusion
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2011-09-16
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Can intravenous iron lower the rate of blood transfusion in gynecologic cancer patients receiving platinum based chemotherapy than oral iron?

Detailed description: Anemia is a common condition during chemotherapy administration. Treatment options usually include oral iron supplementation and blood transfusion. However, oral iron has gastrointestinal side effects, which affects patient compliance, and only a small amount of oral iron can be absorbed from the gastrointestinal tract. Intravenous iron may overcome a block of iron absorption and iron recycling induced by hepcidin. Therefore, it may increase hemoglobin level and reduced blood transfusion in cancer patients receiving chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Age 20-70 years
* Good performance status (Zubrod score \< 2)
* No serious underlying disease
* Normal renal function test
* Normal liver function test
* Platinum based chemotherapy is the first line regimen
* No prior or receiving radiotherapy

Exclusion Criteria:

* Iron hypersensitivity
* Underlying disease which has the risk of iron overload such as chronic kidney disease, major thalassemia
* Progressive disease
* Bone marrow metastasis

Primary outcomes:
measure: Red blood cell (RBC) transfusion rate
timeFrame: 6 months
Secondary outcomes:
measure: total number of red blood transfusion units and number of cycles requiring blood transfusion
timeFrame: 6 months
measure: Number of participants with adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
Study officials:
affiliation: Chulalongkorn University
name: Tarinee Manchana, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Athibovonsuk P, Manchana T, Sirisabya N. Prevention of blood transfusion with intravenous iron in gynecologic cancer patients receiving platinum-based chemotherapy. Gynecol Oncol. 2013 Dec;131(3):679-82. doi: 10.1016/j.ygyno.2013.09.028. Epub 2013 Oct 5.