louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00097526: Bone Mineral Density (BMD) in Adolescents With Growth Hormone Deficiency (GHD)
Official title: Bone Mineral Density in Adolescent Subjects With Growth Hormone Deficiency Who Are Completing Treatment With Nutropin AQ, Nutropin, or Protropin in the National Cooperative Growth Study (NCGS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dwarfism, Pituitary
Turner Syndrome
Keywords: Growth Hormone Deficiency
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-25
Enrollment: 125
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: This study is a multicenter, open-label, postmarketing surveillance study. The substudy will collect information on BMD in adolescents and young adults with GHD or Turner syndrome who are completing GH treatment for statural indications.


Eligibility criteria: Inclusion Criteria:

* Bone age of at least 15 years for girls or at least 16 years for boys within 6 months of obtaining the DXA scan
* Previous enrollment in the NCGS core study, 85-036
* Tanner Stage 4 or greater
* Either spontaneous or induced puberty
* Subjects who plan on terminating GH treatment for statural purposes for one or more of the following reasons: epiphyseal fusion, slowing growth rate indicates that near adult height has been reached, or satisfied with current height

Exclusion Criteria:

* Current therapy with a non Genentech GH product
* Pregnancy (to avoid exposure to low levels of radiation from DXA scanners)
* Bilateral hip replacement
* Weight \>130 kg (286 lb.)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Barbara Lippe, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04310826: Dietary Magnesium in Preventing Low Blood Magnesium Levels in Patients With Ovarian Cancer Receiving Carboplatin Chemotherapy
Official title: Feasibility of Dietary Magnesium Replacement for Prevention of Hypomagnesemia in Ovarian Cancer Patients Receiving Carboplatin Chemotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ovarian Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-17
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This trial studies how well a diet high in magnesium works in preventing low blood magnesium levels (hypomagnesemia) in patients with ovarian cancer receiving carboplatin chemotherapy. Hypomagnesemia is a common side effect of carboplatin-containing chemotherapy. A magnesium rich diet may increase the levels of magnesium in the blood and help prevent hypomagnesemia resulting from carboplatin chemotherapy.

Detailed description: PRIMARY OBJECTIVE:

I. Evaluate intervention feasibility.

SECONDARY OBJECTIVE:

I. Evaluate occurrence of hypomagnesemia and the need for a pharmacy regimen including oral and intravenous magnesium dosage.

EXPLORATORY OBJECTIVE:

I. Explore changes in other electrolytes, weight, and occurrence of chemotherapy delay or discontinuation and hospitalization which can be related to dietary intervention and program completion.

OUTLINE:

Patients receive a dietary magnesium intervention consisting of a food reference list and phone calls or video interviews from a registered dietitian, integrative medicine physician, or a mid-level provider over 10-20 minutes once a week for up to the 6th cycle of chemotherapy (average 15 weeks).

Eligibility criteria: Inclusion Criteria:

* Patients with previously untreated ovarian cancer.
* Receiving carboplatin-containing chemotherapy of at least 6 consecutive cycles.
* Able to tolerate an oral diet.

Exclusion Criteria:

* Prior platinum-based chemotherapy.
* Serum creatinine level \> 1.4 mg/dL prior to treatment.
* Artificial nutrition (e.g. Ensure or Boost) accounts for \> 50% of total calorie intake.

Primary outcomes:
measure: Patient retention rate
timeFrame: Up to 2 years
measure: Dietary adherence rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Occurrence of hypomagnesemia
timeFrame: Up to 2 years
measure: Need for a pharmacy intervention including oral and intravenous magnesium dosage
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorenzo Cohen, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01816126: One-or Two Person Technique and Quality Performance of Colonoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonoscopy Techniques
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2013-03-21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: colon cancer screening population

Brief summary: Colonoscopy can be performed by a one-operator technique with endoscopist personally advancing and withdrawing the scope or by a two-operators technique, with the GI-assistant doing the physical insertion and withdrawal of the scope directed by the endoscopist. Uncontrolled data report that 1 operator technique is associated with a higher adenoma detection rate, although it is also characterized by a lowwer cecal intubation rate and longer intubation time. The aim of present randomized controlled study was to assess whether one technique is better than the other one in terms of colonoscopy quality performances.


Eligibility criteria: Inclusion Criteria:

* adult outpatients colonoscopy for screening or surveillance indications

Exclusion Criteria:

* previous colonic surgery
* poor bowel prep
* inability to provide consent

Primary outcomes:
measure: adenoma detection rate
timeFrame: 4 months
Secondary outcomes:
measure: cecal intubation time
timeFrame: 4 months
Other outcomes:
measure: tolerability
timeFrame: 4 months
Locations:
city: Como
country: Italy
facility: Valduce Hospital
Study officials:
References:
Clinical trial NCT01474226: Metabolic Availability of Lysine From Rice
Official title: Application of the Indicator Amino Acid Oxidation Technique for the Determination of Metabolic Availability of Lysine From Cooked Rice Protein in Adult Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Keywords: lysine
rice
bioavailability
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to investigate the digestibility of the amino acid lysine in cooked rice in adult men using stable isotope technique.

Detailed description: The investigators objective is to determine the metabolic availability (MA) of lysine in cooked white rice protein using the indicator amino acid oxidation (IAAO) technique. Five men will receive graded levels (20, 40, and 60, and 70%) of the lysine requirement of 35 mg/kg/d as a crystalline AA mixture,and cooked rice protein (20, 40 and 60%), respectively.

Eligibility criteria: Inclusion Criteria:

* Healthy Adult males (18 to 50years old)

Exclusion Criteria:

* A history of recent weight loss or illness
* Use of any medication at the time of entry into the study.

Primary outcomes:
measure: Metabolic Availability of lysine
timeFrame: Baseline
measure: Metabolic Availability of lysine
timeFrame: 15 min after intake of the fourth hourly meal (before tracer infusion))
measure: Metabolic Availability of lysine
timeFrame: 30 min after intake of the fourth hourly meal (before tracer infusion))
measure: Metabolic Availability of lysine
timeFrame: 45 min after intake of the fourth hourly meal (before tracer infusion))
Secondary outcomes:
measure: Metabolic Availability of Lysine
timeFrame: Post Tracer Infusion (between 150 and 240 min of tracer infusion)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto, Canada
name: Paul B Pencharz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prolla IR, Rafii M, Courtney-Martin G, Elango R, da Silva LP, Ball RO, Pencharz PB. Lysine from cooked white rice consumed by healthy young men is highly metabolically available when assessed using the indicator amino acid oxidation technique. J Nutr. 2013 Mar;143(3):302-6. doi: 10.3945/jn.112.166728. Epub 2013 Jan 16.
Clinical trial NCT05605626: Learning Skills in Young Specialists and Residents in Operative Vaginal Delivery Using Simulator Models
Official title: Operative Vaginal Delivery in Residents and Young Specialists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Disorder
Delivery Complication
Keywords: vaginal birth
vacuum delivery
operative vaginal birth
mannequin training program
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
Collaborators: name: Santo Spirito Hospital, Italy
First posted: 2022-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants were residents in ObGyn or young specialists in ObGyn (less than 5 years)

Brief summary: Evaluation of different learning programs on persistence of skills in operative vaginal delivery

Detailed description: Investigators enrolled residents and young specialist randomly exposed to simulation of operative vaginal delivery or a lecture before and after experience on simulator program. The two groups were exposed after 8-12 weeks to a second experience of simulator program due to evaluate the improve, deterioration of skills in operative vaginal delivery.

12-months persistence of skills were evaluated

Eligibility criteria: Inclusion Criteria: residents or young specialists (less than 5 years after ending of residency) -

Exclusion Criteria: medical students before MD

-

Primary outcomes:
measure: improving and retaining skills in two different groups of teaching programs
timeFrame: 12 weeks and 1 year
Secondary outcomes:
measure: improve skills in obstetric emergencies considering year of formation and teaching programs
timeFrame: 12 weeks and 1 year
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: University of Chieti
state: CH
Study officials:
References:
Clinical trial NCT01459926: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid Induced Constipation
Keywords: Opioid induced constipation
OIC
Constipation
Opioid side effects
Morphine induced constipation
Opioid therapy
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects with Opioid-Induced Constipation


Eligibility criteria: Inclusion Criteria:

* History of constipation with onset after initiation of opioid therapy
* Self-reported OIC of approximately 3 spontaneous bowel movements (SBMs) per week or less for each week over at least the previous two week period
* Have used chronic opioids with a total daily dose ≥30 mg of morphine equivalent units (MEU, Appendix 7) for the 12 weeks preceding the Screening Visit. Subjects should have used a stable daily regimen of opioids for at least the 2 weeks preceding the Screening Visit
* Willing to stop all laxatives and other bowel regimens with the exception of bisacodyl/enema treatment allowed per protocol throughout the OIC confirmation, treatment, and follow-up periods

Exclusion Criteria:

* Have participated in a clinical trial of an investigational drug or medical device within 30 days prior to Screening
* Have any condition that may affect drug absorption, (e.g., previous GI surgery)
* Any other condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety or tolerability of the investigational drug, or prevent compliance with the study protocol

Primary outcomes:
measure: Change from baseline in the weekly average CSBMs over Weeks 2 to 5 of treatment
timeFrame: Between weeks 2 and 5
Secondary outcomes:
measure: Change from baseline in the weekly SBM frequency in the last week of treatment
timeFrame: baseline and 5 weeks
Other outcomes:
Locations:
city: Foley
country: United States
facility: G and L Research, LLC
state: Alabama
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02054026: Impact Evaluation of the Reducing the Risk Program
Official title: Impact Evaluation of the Reducing the Risk Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Lead sponsor: Mathematica Policy Research, Inc.
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 2220
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of an eight-hour version of Reducing the Risk on outcomes such as sexual initiation, condom and contraceptive use, number of sexual partners, and pregnancy.


Eligibility criteria: Inclusion Criteria:

* 9th grader
* Attends participating school

Primary outcomes:
measure: Sexual Initiation
timeFrame: 2-years post intervention
Secondary outcomes:
measure: Sexual Initiation
timeFrame: 1-year post intervention
measure: Contraceptive use
timeFrame: 1-year post intervention
measure: Contraceptive use
timeFrame: 2-years post intervention
measure: Number of sexual partners
timeFrame: 1-year post intervention
measure: Number of sexual partners
timeFrame: 2-years post intervention
Other outcomes:
measure: Attitudes towards healthy relationships and sexual activity
timeFrame: 1-year post intervention
measure: Attitudes towards healthy relationships and sexual activity
timeFrame: 2-years post intervention
measure: Knowledge of Sexually Transmitted Diseases
timeFrame: 1-year post intervention
measure: Knowledge of Sexually Transmitted Diseases
timeFrame: 2-years post intervention
measure: Career and Education Goals
timeFrame: 1-year post intervention
measure: Career and Education Goals
timeFrame: 2-years post intervention
Locations:
city: Bardstown
country: United States
facility: Bardstown High School
state: Kentucky
city: Bowling Green
country: United States
facility: Warren Central High School
state: Kentucky
city: Bowling Green
country: United States
facility: Warren East High School
state: Kentucky
city: Bowling Green
country: United States
facility: Greenwood High School
state: Kentucky
city: Cecilia
country: United States
facility: Central Hardin High School
state: Kentucky
city: Edmonton
country: United States
facility: Metcalfe County High School
state: Kentucky
city: Elizabethtown
country: United States
facility: Elizabethtown High School
state: Kentucky
city: Franklin
country: United States
facility: Franklin-Simpson High School
state: Kentucky
city: Hodgenville
country: United States
facility: LaRue High School
state: Kentucky
city: Lebanon
country: United States
facility: Marion County High School
state: Kentucky
city: Radcliff
country: United States
facility: North Hardin High School
state: Kentucky
city: Russellville
country: United States
facility: Logan County High School
state: Kentucky
city: Russellville
country: United States
facility: Russellville Junior/Senior High School
state: Kentucky
Study officials:
affiliation: Mathematica Policy Research
name: Robert Wood, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00477126: Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®
Official title: Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® in Thai Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ritonavir generic capsule
Norvir®
Thailand
Determine bioequivalence between Norvir and GPO ritonavir
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: The Government Pharmaceutical Organization
First posted: 2007-05-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.

Detailed description: This study will be performed to evaluate if the new generic GPO ritonavir product is bio-equivalent to Norvir and to compare the short-term tolerability and safety profiles.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Healthy male or female 18-45 years old
* Documented negative test for HIV-1 infection \< 1 wk prior to start of study and with no risk of
* HIV exposure in the last 6 months
* For female subjects: documented negative pregnancy test \<3 wk prior to start of study, not breastfeeding
* BMI 18-25
* Normal physical examination
* Normal CBC, BUN, Cr, AST, ALT, Total bilirubin, no evidence of active or chronic HBV or HCV Infection

Exclusion Criteria:

* History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the study.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* Inability to understand the nature and extent of the study and the procedures required.
* Participation in a drug study within 60 days prior to the first dose.
* Febrile illness within 3 days before the first dose.
* Use of concomitant medication
* Smoke cigarettes not more than 10 cigarettes a day.
* Drink alcohol not more than 2 units a day
* Discontinue smoking and alcohol for at least 1 month before enrollment.
* Take other medication regularly
* Involvement in any drug addiction
* Heart disease, hypertension, liver disease, kidney disease, GI disease, allergic disease or other diseases which may interfere with the PK of study drugs

Primary outcomes:
measure: Establish bioequivalence of generic GPO ritonavir, with Norvir® as the reference drug.
timeFrame: 2 months
Secondary outcomes:
measure: Evaluate the short-term tolerability and safety profiles of generic ritonavir in healthy male and female volunteers.
timeFrame: 2 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
name: Kiat Ruxrungtham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06676826: Treatment of Periodontal Intra-bony Defects With a Volume Stable Collagen Matrix or Deproteinized Bovine Bone Mineral With 10% Collagen
Official title: Treatment of Periodontal Intra-bony Defects With a Volume Stable Collagen Matrix or Deproteinized Bovine Bone Mineral With 10% Collagen. A 12-month Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 80
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: To compare the healing of intrabony periodontal defects treated with either open flap debridement and a volume-stable collagen matrix (VCMX) or a deproteinized bovine bone mineral with 10% collagen. The results will shed light on the clinical potential of VCMX in regenerative periodontal surgery and help to develop new treatment strategies.


Eligibility criteria: Inclusion Criteria

* Patients with localized or generalized periodontitis Stage III and Stage IV, Grade A-B-C
* Males and females
* Age at least 18 years and older
* Presence of interdental intra-bony defects (I, II and III walls) in either the maxilla or the mandible with a PD ≥ 6 mm
* Defects with an intra-bony component \&amp;gt; 3 mm for both groups
* Intra-bony defect located only at one aspect (mesial or distal)
* Presence of at least 2 mm of keratinized soft tissue. Exclusion Criteria
* Patients with systemic disease that could interfere with periodontal wound healing
* Prolonged antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery
* Pregnant or lactating
* Smokers with \&amp;gt; 10 cig./day
* Patients with FMPS and FMBS \&amp;gt; 25 % after completion of non-surgical periodontal therapy
* Multi-rooted teeth with furcation involvement
* Third molars
* Teeth with circumferential defects
* Interdental craters
* Written Informed Consent

Primary outcomes:
measure: Clinical attachment level (CAL) change
timeFrame: 12 months
Secondary outcomes:
measure: Microbiological analysis
timeFrame: 1, 3, 12 weeks
measure: Bleeding on probing (BoP)
timeFrame: Baseline, 12 months
measure: Pocket probing depth (PPD)
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Alexandra Stähli, MD
role: STUDY_CHAIR
References: