louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04050670: A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes
Official title: Effect of Injection Site on the Relative Bioavailability of a Single Dose of Tirzepatide in Subjects With Low and High Body Mass Indices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-08-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
* Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening
* Are agreeable to receiving study treatment by injections under the skin

Exclusion Criteria:

* Have known allergies to tirzepatide or related compounds
* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
* Have a prior history of malignant disease(s) in the past 5 years prior to screening
* Smoke more than the equivalent of 10 cigarettes per day
* Is a known user of drugs of abuse

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])
timeFrame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose
measure: PK: Maximum Concentration (Cmax) of Tirzepatide
timeFrame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02666170: Effects of Alpha-acid Lipoic in PCOS Women
Official title: Effects of 6 Months of Alpha-Lipoic Acid Treatment on Clinical, Endocrine ed Metabolic Features in Women Affected by PCOS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effects of six months treatment with alpha-lipoic acid on clinical, endocrine and metabolic features in women affected by PCOS. Menstrual pattern, anthropometric parameters, hirsutism score, ultrasound ovarian featureas, an oral glucose tolerance test and hormonal assays are evaluated before and after therapy.


Eligibility criteria: Inclusion Criteria:

* women with PCOS in accordance with Rotterdam criteria

Exclusion Criteria:

* pregnancy
* past history of cardiovascular diseases
* diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
* hypertension
* significant liver or renal impairment
* other hormonal dysfunction (hypothalamic, pituitary, thiroidal or adrenal)
* neoplasms.

Primary outcomes:
measure: Number of cycles in six months of therapy
timeFrame: 6 months
Secondary outcomes:
measure: Hirsutism score
timeFrame: 6 months
measure: Insulin levels
timeFrame: 6 months
measure: androstenedione levels
timeFrame: 6 months
measure: testosterone levels
timeFrame: 6 months
measure: free androgen index
timeFrame: 6 months
measure: total cholesterol
timeFrame: 6 months
measure: LDL-cholesterol
timeFrame: 6 months
measure: tryglycerides levels
timeFrame: 6 months
measure: DHEAS levels
timeFrame: 6 months
measure: AMH levels
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04517370: CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer
Official title: CO2 Laser Therapy for the Treatment of GSM in Patients With Breast Cancer A Comparative, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Genitourinary Syndrome of Menopause
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Given the need for an effective, non-hormonal treatment for Genitourinary syndrome of menopause GSM) symptoms in breast cancer survivors, the reported efficacy of fractional CO2 laser as such a treatment in retrospective studies, the study aims to evaluate the efficacy of CO2 laser for the treatment of GSM in breast cancer patients, in a prospective, randomized, blinded, placebo-controlled trial.


Eligibility criteria: Inclusion criteria:

1. Patients diagnosed with breast cancer
2. Menopause: spontaneous, surgical or chemotherapy induced
3. One or more GSM Symptoms: dryness, irritation, burning, pain, dyspareunia, dysuria
4. On exam, clinical findings of atrophy: thin, dry, pale vagina
5. Age\>18
6. Normal Pap smear within 3 years

Exclusion criteria:

1. Menstruation
2. Chemotherapy
3. Vaginal bleeding which did not underwent evaluation
4. Concurrent treatment with topical estrogen
5. Previous vulvar, vaginal or cervical dysplasia\\ cancer

Primary outcomes:
measure: Change in dryness
timeFrame: Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.
measure: Change in dyspareunia
timeFrame: Follow up after 3 treatments and at 1 month, 3 months and 6 months after last treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Lapid
country: Israel
facility: Ahinoam Lev-Sagie
Study officials:
affiliation: Hadassah Medical Organization
name: Ahinoam Lev-Sagie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04510870: Iron Deficiency as an Ignored Cause of Infertility
Official title: Iron Deficiency as an Ignored Cause of Infertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Iron Deficiency
Infertility
Keywords: low ferritin
infertility
in vitro fertilization (IVF)
intracytoplasmic sperm injection (ICSI)
assisted reproductive technology (ART)
Lead sponsor: Dextra Fertility Clinic
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Iron deficiency may play a critical role in human infertility, oocyte quality and may even play a role in endometrial receptivity. By correcting iron deficiency, low ferritin values, in infertile women with intravenous iron supplementation, embryo quality and pregnancy rates may improve.

The main objective is to evaluate the effect of intravenous iron supplementation on embryo quality (number of good quality blastocysts).

Randomized, double blind, parallel group, cross-over study of ferric carboxymaltose compared to placebo (NaCl infusion).


Eligibility criteria: Inclusion Criteria:

* Patient's 18 to 42 years and in full consent
* Ferritin ≤ 30 ug/l
* Anti-mullerian hormone (AMH) \> 1ug/l
* Planned for IVF/ ICSI treatment
* Diagnosis for treatment: tubal factor, male factor or unexplained infertility (NUD)

Exclusion Criteria:

* Endometriosis
* Poor responder
* Inflammatory bowel disease (IBD), colitis ulcerosa
* Rheumatoid arthritis
* Renal insufficiency
* Cardiac insufficiency
* Body Mass Index (BMI) over 35
* Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products
* Clinical evidence of iron overload or disturbances in the utilization of iron
* use of atosiban or filgrastim during stimulation or embryo transfer

Primary outcomes:
measure: Number of good quality blastocysts
timeFrame: day 5-7 after oocyte pick up
Secondary outcomes:
measure: blastulation rate
timeFrame: day 5-7 after oocyte pick up
measure: ongoing pregnancy/ pregnancy rate
timeFrame: 10 weeks after oocyte pick up,at oocyte pick up it counted to be 2 weeks of gestation.
measure: mature oocyte rate
timeFrame: 1 day after oocyte pick up
measure: fertilization rate
timeFrame: 1 day after oocyte pick up
measure: implantation rate
timeFrame: 5 weeks after embryo transfer
Other outcomes:
measure: endometrial thickness
timeFrame: 1 month after infusion, at the time of embryo transfer
Locations:
city: Helsinki
country: Finland
facility: Dextra Fertility Clinic
Study officials:
affiliation: senior consultant
name: Annika Tulenheimo-Silfvast, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03798470: FAVOR Opioid Recovery Coaching Evaluation
Official title: FAVOR Opioid Recovery Coaching Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opiate Abuse
Opiate Overdose
Opioid-use Disorder
Keywords: opioid
overdose
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: FAVOR (Faces and Voices of Recovery) OF GREENVILLE
name: South Carolina Department of Alcohol and Other Drug Abuse Services
First posted: 2019-01-10
Enrollment: 150
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: The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.

These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.

Detailed description: The Emergency Department (ED) is an ideal location to identify patients in need of treatment for opioid addiction. A local non-profit community-based addiction recovery program, Faces and Voices of Recovery (FAVOR) utilizes a peer recovery coaching model applied to substance use disorders by identifying, training, credentialing and supervising individuals who have been in recovery for at least 2 years.These peer recovery coaches become the primary workforce in this community-based model. FAVOR provides no-cost comprehensive services for addiction recovery. The investigators hypothesized that having FAVOR Recovery Coaches (FRC) evaluate patients during an ED visit for opioid overdose would result in a high degree of engagement from the patients and serve as an opportunity to begin treatment for addiction.

Eligibility criteria: Inclusion Criteria:

* Patients presenting to the ED with opioid overdose or withdrawal

Exclusion Criteria:

* Age \<18
* Known pregnant female
* Prisoners

Primary outcomes:
measure: Percentage of patients with active involvement in recovery
timeFrame: One year
Secondary outcomes:
measure: All-cause Mortality
timeFrame: One year
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
Study officials:
affiliation: Greenville Health System Emergency Medicine
name: Christopher Carey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05043870: Combined Immunosuppression for Pediatric Crohn's Disease
Official title: Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Crohn Disease
Infliximab
Immunosuppression
Children, Only
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 128
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.


Eligibility criteria: Inclusion Criteria:

1. 6-18 years old
2. diagnosis of Crohn's Disease
3. Pediatric Crohn's disease Activity Index (PCDAI)\>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) \>10 before treatment
4. receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)\>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids
5. The patient or legal guardian sign the informed consent documents

Exclusion Criteria:

1. history of biological agents targeting at tumor necrosis factor (TNF)
2. Crohn's Disease-related surgery
3. infections
4. tumors

Primary outcomes:
measure: clinical remission
timeFrame: week 54
measure: endoscopic remission
timeFrame: week 54
Secondary outcomes:
measure: Pediatric Crohn's disease Activity Index score
timeFrame: week0, week2, week6, week14, week22, week30, week38, week46, week54
Other outcomes:
measure: infliximab concentration
timeFrame: week 14, 38
measure: adverse events
timeFrame: within one year
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Huang
role: STUDY_DIRECTOR
References:
Clinical trial NCT03600870: Midodrine in Hepatopulmonary Syndrome
Official title: A Phase 1 Proof-of-concept Clinical Trial Evaluating the Safety and Tolerability of Midodrine in Hepatopulmonary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatopulmonary Syndrome (HPS)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 10
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: This proof-of-concept clinical trial will determine the safety and tolerability of midodrine in patients with hepatopulmonary syndrome (HPS). Exploratory endpoints will assess the effect of midodrine on oxygenation, intrapulmonary shunting and symptoms.


Eligibility criteria: Inclusion Criteria:

* Moderate to very severe hepatopulmonary syndrome, defined as the presence of all of the following:

  1. Liver disease or portal hypertension
  2. Intrapulmonary shunting on contrast-enhanced echocardiogram
  3. Hypoxemia \[A-a gradient ≥15mmHg (or ≥20mmHg if age \>64) and PaO2\<80mmHg on arterial blood gas testing\]
* Ability to provide informed consent
* Ability to comply with study medication use and testing, in the opinion of the principal investigator or co-investigator

Exclusion Criteria:

* Vulnerable study population, including imprisoned individuals, non-English speaking patients
* Participation in other investigational drug studies
* Any of the following conditions:
* Systolic blood pressure\>160mmHg or diastolic blood pressure \>100mmHg
* Heart rate \<50bpm
* Urinary retention at baseline
* Left ventricular ejection fraction \<50%
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Women of child-bearing potential not willing or able to use highly effective methods of birth control

Primary outcomes:
measure: Safety and tolerability (adverse events (AEs))
timeFrame: 6 months
Secondary outcomes:
measure: Arterial Oxygenation
timeFrame: 3 months and 6 months
measure: Diffusion capacity
timeFrame: 3 months and 6 months
measure: Cardiac output
timeFrame: 3 months and 6 months
measure: Intrapulmonary shunting
timeFrame: 3 months and 6 months
measure: Intrapulmonary shunting
timeFrame: 6 months
measure: Symptoms as assessed by Modified Medical Research Council (MMRC)dyspnea scale
timeFrame: 3 months and 6 months
measure: 6 minute walk distance
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Hilary M DuBrock, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00050570: Reducing Eating Disorder Risk Factors
Official title: Interventions to Reduce Eating Disorder Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorders
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-12-17
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a web-based program is effective in reducing the incidence of eating disorders in college women who are at high risk for developing an eating disorder.

Detailed description: Female college students who use unhealthy weight control methods and have body image concerns may be at risk for developing an eating disorder. Developing and evaluating interventions to reduce eating disorders in high-risk populations is of great public health importance.

Participants are randomly assigned to either join a web-based risk-reduction program or receive no intervention. The 9-week risk-reduction program focuses on reducing body image and weight/shape concerns, identifying the risks of eating disorders, and increasing healthy weight regulation practices. The program includes weekly readings, writing assignments, and participation in a moderated electronic discussion group. Changes in body mass index (BMI) and the occurrence of major stressors and psychiatric events are assessed to determine their impact on the incidence of eating disorders. One-year incidence of eating disorders is determined by a diagnostic interview, and follow up may continue for up to 2.5 years.

Eligibility criteria: Inclusion Criteria:

* College students at risk for developing an eating disorder

Exclusion Criteria:

* Suicidal or other severe psychopathology
* Alcohol or drug abuse
* Body mass index (BMI) \< 18 or \> 32
* Current diagnosis of anorexia nervosa, binge eating disorder, or bulimia nervosa and have been in treatment within the past 6 months

Primary outcomes:
measure: Onset of an eating disorder
timeFrame: 2 years
Secondary outcomes:
measure: Change in eating disorder behaviors
timeFrame: 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, Dept. of Psychiatry and Behavioral Sciences
state: California
Study officials:
References:
Clinical trial NCT00298870: Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Tuberculosis
Keywords: pulmonary tuberculosis
isoniazid
arylamine N-acetyltransferase 2
pharmacogenomics
genetic polymorphisms
individualized medicine
drug-induced hepatotoxity
Lead sponsor: Osaka University
Sponsor class: OTHER
First posted: 2006-03-03
Enrollment: 172
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to elucidate whether the individualized medicine based on NAT2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed pulmonary tuberculosis patients
* Informed consent including pharmacogenomic analysis

Exclusion Criteria:

* Abnormal liver and kidney function test before treatment
* Long-term use of steroids and/or immunodepressants
* Inadequate clinical conditions

Primary outcomes:
measure: The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism
Secondary outcomes:
measure: Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy
Other outcomes:
Locations:
city: Habikino
country: Japan
facility: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
state: Osaka
city: Neyagawa
country: Japan
facility: Osaka Hospital, Anti-Tuberculosis Association, Osaka Branch
state: Osaka
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center
state: Osaka
city: Toyonaka
country: Japan
facility: National Hospital Organization Toneyama
state: Osaka
Study officials:
affiliation: Graduate School of Pharmaceutical Sciences, Osaka University
name: Junichi Azuma, MD
role: STUDY_CHAIR
References:
citation: Azuma J, Ohno M, Kubota R, Yokota S, Nagai T, Tsuyuguchi K, Okuda Y, Takashima T, Kamimura S, Fujio Y, Kawase I; Pharmacogenetics-based tuberculosis therapy research group. NAT2 genotype guided regimen reduces isoniazid-induced liver injury and early treatment failure in the 6-month four-drug standard treatment of tuberculosis: a randomized controlled trial for pharmacogenetics-based therapy. Eur J Clin Pharmacol. 2013 May;69(5):1091-101. doi: 10.1007/s00228-012-1429-9. Epub 2012 Nov 14.