louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01676597: Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatopulmonary Syndrome
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2012-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * The study will be a prospective open labelled double blinded randomized controlled study.
* The study will be conducted on patients admitted to Department of Hepatology from 2012 to 2014 at Institute of Liver and Biliary Sciences, New Delhi
* Patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks.
* Patients not responding to this therapy will be given divided into 2 arms with one arm receiving additional Tab Rifaximin 400 mg thrice daily or placebo for 12 weeks.


Eligibility criteria: Inclusion Criteria:

1. Evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography scan or ultrasound, and/or splenomegaly with no other explanation, and/or ascites with no other explanation)
2. Intrapulmonary vascular dilatations (IPVDs) diagnosed on contrast echocardiogram (CE)
3. AaDO2 \> 15 mm Hg on standing room air arterial blood gas (ABG)
4. Ability and willingness to give informed consent

Exclusion Criteria:

* Age \< 18 or \> 64
* Intrinsic significant cardiopulmonary disease
* Inability to perform pulmonary function tests
* Moderate to severe Pulmonary hypertension
* Advanced hepatic encephalopathy
* Inadequate echocardiographic window to allow for accurate transthoracic contrast echocardiography
* Antibiotic use within the last one month
* Listed for liver transplant in next 4 weeks
* Current use of exogenous nitrates
* Active bacterial infections
* Known malignancy
* Known intolerance to Pentoxifylline or rifaximin

Primary outcomes:
measure: Complete response after 3 months of treatment
timeFrame: 3 months
Secondary outcomes:
measure: Development of serious adverse effects leading to withdrawal of the drug
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Naveen Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01181297: Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Keywords: Confirmed milk allergy
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2010-08-13
Maximum age (years): 14
Standard ages: CHILD

Brief summary: The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.


Eligibility criteria: Inclusion Criteria:

* ≤14 years of age
* Essentially asymptomatic for a minimum of 7 days pre-challenge.
* Successful previous consumption of Extensively Hydrolyzed Formula within 1 week of study enrollment
* Medically documented allergy to cow's milk

Exclusion Criteria:

* Presence of underlying systemic disease or other illness
* Used Beta-blockers within 12-24 hours of challenges
* Use of short-acting antihistamines within 3 days
* Use of medium-acting antihistamines within 7 days
* Use of long-acting antihistamines within 6 weeks
* Use of oral steroid medication within 3 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Dept. of Paediatrics, Azienda Ospedaliera di Padova
state: Veneto
city: Utrecht
country: Netherlands
facility: Wilhelmina Children's Hospital
Study officials:
References:
citation: Muraro A, Hoekstra MO, Meijer Y, Lifschitz C, Wampler JL, Harris C, Scalabrin DM. Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status: randomised double-blind, placebo-controlled crossover trial. BMJ Open. 2012 Mar 5;2(2):e000637. doi: 10.1136/bmjopen-2011-000637. Print 2012.
Clinical trial NCT04356105: Protocols of IVF/ICSI in Poor Responders
Official title: Minimal Stimulation in a Combined Letrozole Antagonist Protocol Versus Microflare Protocol in Poor Responders Undergoing Invitrofertilization/ Intracytoplasmic Sperm Injection; Randomized Parallel Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility, Female
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 132
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of poor ovarian responders to be given two different induction protocols at the same time duration of the study
Primary purpose: TREATMENT

Brief summary: Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles

Detailed description: The two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI cycles, primary outcome will be the number of oocytes retrieved.

Eligibility criteria: Inclusion Criteria:

1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:

1. Advanced maternal age
2. Previous poor ovarian response
3. Abnormal tests of ovarian reserve (AFC \< 5-7, AMH \<0.5-1.1 ng/ml)

Exclusion Criteria:

1. Age \> 43 years
2. baseline FSH \>15 mIU/ml
3. Previous ovarian surgery
4. Ovarian endometrioma
5. Uterine anomaly or myoma
6. Any medical disorder
7. Any hormonal disorder eg. hyperprolactinemia
8. BMI \> 30 kg/m2
9. Severe male factor

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 10 to 14 days
Secondary outcomes:
measure: Number of MII oocytes retrieved
timeFrame: 10 to 14 days
measure: Number of fertilized oocytes
timeFrame: 2 days
measure: Number of embryos transferred
timeFrame: Day 3 after ovum pickup
measure: Number of embryos cryopreserved
timeFrame: Day 3 after ovum pickup
measure: Chemical pregnancy rate
timeFrame: 14 days after embryo ransfer
measure: Clinical pregnancy rate
timeFrame: 5 to 7 weeks after embryo transfer
measure: Early miscarriage rate
timeFrame: 12 weeks
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
measure: Live birth rate
timeFrame: 28 to 40 weeks
Other outcomes:
measure: Cancellation rate
timeFrame: 10 to 14 days
measure: Total dose of recombinant FSH
timeFrame: 10 to 14 days
Locations:
city: Cairo
country: Egypt
facility: IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Sarwat Ahwany, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01579305: Safety and Effectiveness of Juvéderm® Volbella With Lidocaine Versus Restylane-L® for Lip Volume Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Volume Enhancement
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-04-17
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate lip fullness 3 months following treatment with Juvéderm® Volbella with Lidocaine or Restylane-L®


Eligibility criteria: Inclusion Criteria:

1. Desire enhancement of his/her vermilion borders and/or vermilion mucosa
2. Have a baseline score of Minimal or Mild, as assessed by the Investigator, according to the 5-point LFS (Minimal, Mild, Moderate, Marked, Very Marked)
3. Have established a realistic Lip Fullness treatment goal that the Investigator agrees is achievable

Exclusion Criteria:

1. Have undergone cosmetic facial, lip or perioral procedures \[e.g., face-lift, or other surgeries, which may alter the appearance of the lips or perioral area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy\] anywhere in the face or neck, or Botox® Cosmetic injections in the lower face (below the orbital rim), within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 6 months prior to study entry
2. Have ever received semi-permanent fillers or permanent facial implants, e.g., calcium hydroxyapatite, L-polylactic acid, polymethylmethacrylate (PMMA), silicone, expanded polytetrafluoroethylene (ePTFE) anywhere in the lips, or be planning to be implanted with any of these products at any time during the study

Primary outcomes:
measure: Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cannes
country: France
city: Glasgow
country: United Kingdom
Study officials:
References:
citation: Raspaldo H, Chantrey J, Belhaouari L, Saleh R, Murphy DK. Juvederm volbella with lidocaine for lip and perioral enhancement: a prospective, randomized, controlled trial. Plast Reconstr Surg Glob Open. 2015 Apr 7;3(3):e321. doi: 10.1097/GOX.0000000000000266. eCollection 2015 Mar.
Clinical trial NCT02451605: Regional Anesthesia for Knee Prothesis Surgery
Official title: Regional Blockade for Knee Prothesis Surgery: Comparison Between Femoral, Sciatic and Adductor Canal Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Knee Replacement
Keywords: surgery
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve) for total replacement knee surgery.

Detailed description: Adductor canal block shows a beneficial effect for knee surgery. Mainly because he prevent for muscular weakness; adverse effect meet with femoral block and delaying the early active mobilization.

The investigators want to compare the efficacy and safety of this block compared to the femoral and sciatic block.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for total knee replacement surgery.

Exclusion Criteria:

* refusal to study,
* coagulation disorder,
* infection at the puncture site,
* preexisting neuropathy,
* allergy to local anesthetics,
* renal or hepatocellular insufficiency,
* context of chronic pain,
* drugs abuse,
* pregnant patient.

Primary outcomes:
measure: Pain measurement with numeric pain scale : from 0 to 10 (maximal pain) in rest condition
timeFrame: up to day 7
measure: Pain measurement with numeric pain scale (from 0 to 10) during active motorized mobilization (Kinetic)
timeFrame: up to day 7
Secondary outcomes:
measure: Postintervention nausea vomiting
timeFrame: at hour 0, at hours 6, at day 1
measure: Patient satisfaction
timeFrame: at day 1
measure: Opioid consumption
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University og Liege, University Hospital
Study officials:
affiliation: University of Liege
name: Jean-Francois Brichant
role: STUDY_CHAIR
References:
Clinical trial NCT00588705: The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer
Official title: The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Counseling
Keywords: Daughters
Communication
genetic risk
Genetic Counseling
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Monash University
First posted: 2008-01-08
Enrollment: 27
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Memorial Sloan-Kettering Cancer Center (MSK) breast cancer patients seen by the clinical genetics service (CGS)and their daughters

Brief summary: The purpose of this study is to first understand how MSKCC Clinical Genetics Service doctors talk to women with breast cancer about any genetic risks they might carry, and if they help women to think about what they might say, in turn, to their relatives, especially their daughters.

A second part of the study asks women for their opinions about when and how their daughters should be told about any genetic risks.

All of this will help us develop teaching methods to help our doctors improve the way they talk about genetic risk when women with breast cancer have adolescent daughters.


Eligibility criteria: Inclusion Criteria:

* Women seen in the MSK CGS Service who have a diagnosis of breast cancer or
* a family history of breast cancer and
* have biological daughter(s) in the age range 12-20 years will be eligible to participate in Phase I \& II.
* Women who were consented to Phase I will automatically be eligible for Phase II.

Exclusion Criteria:

* Women seen in the MSK CGS Service will be ineligible if they have no diagnosis of breast cancer and no family history of breast cancer,
* do not have a biological daughter,
* or have a biological daughter fewer than 12 or greater than 20 years(unless they were consented to Phase 1).
* Women will be ineligible if they are not English speaking,
* have intellectual or cognitive impairment,
* or active mental illness rendering them incapable of giving informed consent, such as might occur with active psychosis.

Primary outcomes:
measure: Is a demonstration of the effectiveness of the module in changing the behavior of clinicians after taking part in the communication skills module.
timeFrame: conclusion of study
Secondary outcomes:
measure: To examine the views of women about the provision of genetic risk information to their daughters.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Smita Banerjee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03266705: A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood
Official title: A Phase 1, Open-label, Randomized, Crossover, Multiple Dose, Pivotal Bioequivalence Study To Compare Pf-06291826 4 X 20 Mg Tafamidis Meglumine And 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Administered Under Fasted Conditions To Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 2 different formulations and doses of tafamidis will be compared. All subjects will receive both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects will be fasted before taking the drug. Blood samples will be taken to measure the amount of tafamidis starting on day 7 and ending on day 8. At least 16 days after the first formulation/dose is given, all subjects will repeat the procedure with the other formulation/dose.


Eligibility criteria: Inclusion Criteria:

* Healthy males of females of non-childbearing potential
* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)

Exclusion Criteria:

* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer)
* Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.

Primary outcomes:
measure: Area under the concentration-time curve (AUC)
timeFrame: 24 hours
measure: maximum observed plasma concentration (Cmax)
timeFrame: 24 hours
Secondary outcomes:
measure: minimum observed plasma concentration (Cmin)
timeFrame: 24 hours
measure: Time to maximum observed plasma concentration (Tmax)
timeFrame: 24 hours
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 NCT02432105: Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
Official title: Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media With Effusion in Children
Otitis Media Recurrent
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-05-01
Enrollment: 470
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).


Eligibility criteria: Inclusion Criteria:

* Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion.
* Suspected bacterial infection at time of surgery in at least 1 ear.
* Willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities.
* Legally Authorized Representative (LAR) must read and sign the informed consent.
* Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.
* Middle ear pathology in either ear other than otitis media.
* Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug.
* Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the Investigator.
* Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Subjects With Sustained Clinical Cure at Day 8
timeFrame: Day 8
Secondary outcomes:
measure: Percentage of Subjects With Microbiological Success at Day 14
timeFrame: Day 14
measure: Time to Cessation of Otorrhea
timeFrame: Up to Day 14
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, Ophtha, GCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT02186405: Effects of Levothyroxine Treatment on Hemodynamic and Renal Functions in Subclinical Hypothyroidism
Official title: Effects of Levothyroxine Treatment on Hemodynamic and Isotopic Renal Functions in Subclinical Hypothyroidism
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Subclinical hypothyroïdism
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and normal T4 are less known and the indications for treatment of subclinical hypothyroidism are subject to controversies.

The investigators propose to assess whether the hormone replacement for subclinical hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and renal functions and which mechanisms are involved.

Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried out before and 6 months after substitution.

Detailed description: Animal experimental hypothyroidism is associated with renal and hemodynamic abnormalities. In human, exact measurements of GFR showed a decline in GFR after thyroidectomy and an increase in GFR and renal blood flow after hormone replacement. Renal and cardiovascular effects of subclinical hypothyroidism, defined by a high TSH and normal T4 are less known and the indications for treatment of subclinical hypothyroidism are subject to controversies. A retrospective study suggests that treatment of subclinical hypothyroidism may slow the degradation rate of renal function estimated by MDRD. However, the potential hemodynamic benefit of treatment has not yet been studied.

The investigators propose to assess whether the hormone replacement for subclinical hypothyroidism in patients with chronic kidney disease is beneficial for hemodynamic and renal functions and which mechanisms are involved.

Isotopic measurements of glomerular filtration and renal blood flow and an hemodynamic evaluation by transthoracic echocardiography and flow-mediated vasodilation will be carried out before and 6 months after substitution. This open prospective study will include 16 patients in order to detect an increase of 1.2 standard deviation for the measured glomerular filtration.

Eligibility criteria: Inclusion Criteria:

* over 18 years
* chronic kidney disease
* subclinical hypothyroidism

non-inclusion Criteria:

* insulin-dependent diabetes
* dialysis

Primary outcomes:
measure: KIDNEY CLEARANCE
timeFrame: Before treatment and 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nephrology Department
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Guillaume FAVRE, PhD
role: PRINCIPAL_INVESTIGATOR
References: