louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06142084: Digestibility of Different Plant-based Proteins in Humans With Ileostomy
Official title: True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ileostomy - Stoma
Keywords: Protein
Plant-based
Digestibility
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 11
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 goal of this interventional study is to learn about the digestibility of different plant-based proteins in adults (age 18-75) with an ileostomy.

The main questions the study aims to answer are:

1. How does the digestibility of proteins in the small intestine differ between different plant-based proteins?
2. Which proteins and amino acids are not digested or absorbed in the small intestine and are available for further metabolic processes in the large intestine?
3. How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins?
4. Can the in vivo results be compared to results from existing in vitro models?

Participants will consume five different protein meals (oat protein - high bioavailable, oat protein - low bioavailable, pea protein - high bioavailable, pea protein low bioavailable, protein-free meal) on five different study days in a random order. Five hours after consuming the test meals ileostomy bags will be collected and the content will be analysed to answer the above mentioned research questions.


Eligibility criteria: Inclusion Criteria:

* Age: 18 - 75 years
* Body mass index: 18.5 - 30 kg/m2
* (double-loop) Ileostomy with an intact small bowel
* Signed informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Ileostomy \< 3 months before the study
* Any clinically significant present or past disease/condition other than colon cancer which in the investigator's opinion could interfere with the results of the trial
* Any clinically significant present or past medication which in the investigator's opinion could interfere with the results of the trial

Primary outcomes:
measure: True ileal digestibility of different plant-based proteins
timeFrame: 0-5 hours after consumption of test meal (on all 5 study days)
Secondary outcomes:
measure: Protein and metabolite profiles in ileostomy digesta
timeFrame: 0-5 hours after consumption of test meal (on all 5 study days)
measure: Differences between in vivo and in vitro data
timeFrame: In vivo data: 0-5 hours after consumption of test meal (on all 5 study days)
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
References:
Clinical trial NCT06093984: Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
Official title: A Randomized Clinical Trial Comparing Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 260
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the difference in cumulative live birth rates between dual ovarian stimulation and two antagonist stimulations in poor ovarian responders.

Detailed description: Studies have shown the ability to obtain oocytes with equivalent quality from the follicular and the luteal phase, and a higher number of oocytes within one cycle when using dual ovarian stimulation (duostim). This could be particularly relevant for women with poor ovarian responders (POR). Whether the cumulative live birth rates differ after duostim and two antagonist stimulations in POR remains controversial.

Eligibility criteria: Inclusion Criteria:

* Women with POR were defined with adjusted Bologna criteria, at least two of the three following criteria: advanced maternal age (40 years); 3 oocytes in previous IVF; and antral follicle count (AFC) 5 and/or anti-Mu¨llerian hormone (AMH) 1.1 ng/ml (this criterion was mandatory)
* Aged from 20 to 44 years
* Body mass index (BMI) from 19 to 32 kg/m2
* No more than two previous IVF cycles were recruited

Exclusion Criteria:

* Amenorrhoea
* Follicle stimulating hormone (FSH) 20 IU/L or AFC 1
* Women with a partner with an extremely severe sperm anomaly or sperm donor use

Primary outcomes:
measure: Cumulative live birth rate
timeFrame: 36 months
Secondary outcomes:
measure: Time to live birth (TTLB)
timeFrame: 36 months
measure: Total amount of Gn used during ovarian stimulation
timeFrame: 24 months
measure: Number of retrieved oocytes
timeFrame: 24 months
measure: Clinical pregnancy rate
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04714684: The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
Official title: The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fissure in Ano
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness of fitostimoline proctogel in the anal fissure healing and in the need for invasive interventions (primary endpoints) and in the healing of the fissure (secondary endpoint) using Fitostimoline in addition to or without other topical devices available on the market.

Three groups will be established: one for the exclusive use of fitostimoline, the second for the use of fitostimoline in addition to one of the other topical devices already on the market and the third group only for the use of other topical therapies.


Eligibility criteria: Inclusion Criteria:

* None previous therapies for anal fissure
* Symptomatic anal fistula
* Signing of informed consent
* age \>18 years old

Exclusion Criteria:

* Patients unable to complete the questionnaire and with a legal guardian.
* Patients with concomitant abscess/fistula
* Pregnant women

Primary outcomes:
measure: control of anal fissure symptoms
timeFrame: 30 days
measure: need of invasive treatment
timeFrame: 30 days
Secondary outcomes:
measure: anal fissure healing
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01972984: Feasibility Study of Presurgical Hormone Therapy (Anastrozole) in Breast Cancer Patients
Official title: The NEO (NEOADJUVANT ENDOCRINE OUTCOMES) TRIAL: Neoadjuvant Endocrine Therapy for Primary Breast Cancer: Investigation of Clinical and Translational Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Estrogen receptor positive
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2013-10-31
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. Women with operable breast cancer with a 2-8 week preoperative waiting period will accept preoperative therapy trials and specifically taking a standard drug for breast cancer such as anastrozole in this study
2. Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor.
3. Degree of response to short term anastrozole varies with a) duration of treatment and b) breast cancer subtype (based on initial pre-treatment biomarker status)


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed postmenopausal women (Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL and estradiol \< 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.)
2. Confirmation of estrogen receptor positive invasive carcinoma on core biopsy
3. Patients whose cancers are palpable and have been deemed to be "operable" by the surgeon
4. Surgery is planned for the next 2-8 weeks.

Exclusion Criteria:

1. History of hormone replacement therapy in the last 6 months
2. Previous treatment by tamoxifen or aromatase inhibitor treatment in six months
3. Known hypersensitivity or contraindications to aromatase inhibitors
4. Known metastatic disease on presentation
5. Recurrent breast cancer
6. Inability to give informed consent

Primary outcomes:
measure: Percentage of patients who fit the eligibility criteria that consent to the study; withdraw after consent from the study.
timeFrame: up to 18 months
Secondary outcomes:
measure: Measure the changes in ER, PR, Her2 and Ki67 labelling index on pre- and post treatment tumor tissue
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Cancer Centre
name: Angel Arnaout, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00869284: Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas
Official title: Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: High-dose chemotherapy
aggressive NHL
high-risk
PBSC
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2009-03-25
Enrollment: 45
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.

Detailed description: High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years

Eligibility criteria: Inclusion Criteria:

* patients aged from 15 to 60 years
* previously untreated
* histologically proven aggressive NHL
* high aa-IPI (equal to 3)
* proper underlying organ function

Exclusion Criteria:

* transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma

Primary outcomes:
measure: Complete response
timeFrame: end of treatment
Secondary outcomes:
measure: overall survival disease free survival
timeFrame: 10 years after treatment
Other outcomes:
Locations:
city: Tours
country: France
facility: Emmanuel Gyan
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Noël MILPIED, MDPD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monjanel H, Deconinck E, Perrodeau E, Gastinne T, Delwail V, Moreau A, Francois S, Berthou C, Gyan E, Milpied N; GOELAMS. Long-term follow-up of tandem high-dose therapy with autologous stem cell support for adults with high-risk age-adjusted international prognostic index aggressive non-Hodgkin Lymphomas: a GOELAMS pilot study. Biol Blood Marrow Transplant. 2011 Jun;17(6):935-40. doi: 10.1016/j.bbmt.2010.11.017. Epub 2010 Nov 23.
Clinical trial NCT06041984: Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy
Official title: Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy: a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
PHASE2
Conditions: Glycopyrrolate
Colonoscopy
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 to determine the antiperistaltic effect and safety of glycopyrrolate and whether the use of glycopyrrolate is beneficial for colonoscopy and colonoscopic polypectomy.

Detailed description: Colonic spasm is a major adverse event affecting colonoscopy.The current mainstay for the prevention of colonic spasm is the use of antispasmodic.Glycopyrrolate is a long-acting quaternary ammonium anticholinergic drug.The study is designed as a randomized, double-blind, placebo-controlled study of the efficacy and safety of glycopyrrolate in participants receiving colonoscopy and colonoscopic polypectomy. Patients at our center who met the inclusion criteria were randomized into the glycopyrrolate group and the placebo group, and then statistically analyzed whether there was any difference in the incidence of spasticity, spasticity scores, polyp treatment time, and satisfaction with endoscopist operation between the two groups.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years old.
* Outpatients and inpatients with lesions to be resected under colonoscopy.
* Participants voluntarily participated and signed informed consent forms.

Exclusion Criteria:

* Pregnancy status and lactating women.
* With glaucoma, myasthenia gravis, hyperthyroidism, chronic renal insufficiency, and inflammatory bowel disease.
* With obstructive gastrointestinal diseases such as pyloric obstruction, paralytic ileus, and achalasia of the cardia.
* With obstructive urinary tract diseases such as prostatic hyperplasia and dysuria.
* With heart disease such as arrhythmia (bradycardia, tachycardia, ventricular fibrillation, atrial fibrillation, etc.), coronary heart disease, congestive heart failure.
* With a history of previous abdominal or intestinal surgery.
* Anticholinergic drugs were administered 48 hours before surgery.

Primary outcomes:
measure: Incidence of intestinal spasm
timeFrame: During Colonoscopy
Secondary outcomes:
measure: inhibitory effect score
timeFrame: During Colonoscopy
measure: Polyp Treatment Time
timeFrame: During Colonoscopy
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital Of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Guangyou Duan, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05134584: Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders
Official title: Efficacy and Safety of Linaclotide in Patients With Overlap of Functional Dyspepsia and Constipation-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Functional Dyspepsia
Constipation-predominant Irritable Bowel Syndrome
Keywords: functional dyspepsia
irritable bowel syndrome
constipation
linaclotide
lactulose
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 78
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: This study aims to assess the efficacy and safety of linaclotide in patients with overlapping symptoms of both functional dyspepsia (FD) and constipation-predominant irritable bowel syndrome (IBS-C).

Detailed description: After being informed about the content and risks of the research, all eligible patients giving written informed consent will be randomly allocated in a 2:1 ratio to linaclotide (290μg, once daily) or lactulose (20mL, once daily). Treatment will last consecutively for 4 weeks, and patients' symptoms will be assessed before and after four-week treatment.

Eligibility criteria: Inclusion Criteria:

1. Outpatients
2. Diagnosis of FD (including postprandial distress syndrome \[PDS\] with or without epigastric pain syndrome \[EPS\]) (Rome Ⅲ criteria)
3. Diagnosis of IBS-C (Rome Ⅲ criteria)

Exclusion Criteria:

1. Helicobacter Pylori infection
2. GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents
3. Pregnancy

Primary outcomes:
measure: Treatment satisfaction assessed by the VAS
timeFrame: Week 4
Secondary outcomes:
measure: Changes in stool frequency
timeFrame: Baseline and Week 4
measure: Changes in stool consistency
timeFrame: Baseline and Week 4
measure: Changes in defecation straining score
timeFrame: Baseline and Week 4
measure: Changes in defecation time
timeFrame: Baseline and Week 4
measure: Changes in sensation of complete evacuation
timeFrame: Baseline and Week 4
measure: Changes in lower abdominal discomfort
timeFrame: Baseline and Week 4
measure: Changes in lower abdominal pain
timeFrame: Baseline and Week 4
measure: Changes in FD symptoms
timeFrame: Baseline and Week 4
measure: Changes in the anxiety status
timeFrame: Baseline and Week 4
measure: Changes in the depression status
timeFrame: Baseline and Week 4
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJiH
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Shengliang Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03639779: Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Saline for Dystrophic and Idiopathic Calcinosis Cutis
Official title: A Comparative Study of the Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Normal Saline for the Treatment of Dystrophic and Idiopathic Calcinosis Cutis, A Double-Blind Randomized Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Calcinosis Cutis
Keywords: Calcinosis cutis
sodium thiosulfate
sodium chloride
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel two-arm study comparing sodium thiosulfate and saline control.
Primary purpose: TREATMENT

Brief summary: The purpose of our research is to compare the effectiveness of 125mg/50ml sodium thiosulfate (STS) solution to normal saline (0.9% sodium chloride) when injected intralesionally for the treatment of calcinosis cutis. Our specific aim is to assess the response of dystrophic and idiopathic calcinosis cutis to the injections of sodium thiosulfate in our patients.

Detailed description: Our specific aim is to assess the response of dystrophic and idiopathic calcinosis cutis to the injections of sodium thiosulfate in our patients.

Eligibility criteria: Inclusion Criteria:

* Male or female adult 18 years of age or older
* Must have health insurance will be eligible to participate
* Must have a current diagnosis of dystrophic or idiopathic calcinosis cutis
* Subjects must have at least 2 lesions of at least 2mm in size

Exclusion Criteria:

* Unable to read and speak English
* Allergy to any component of the sodium thiosulfate solution
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Women who are breastfeeding
* Prisoners

Primary outcomes:
measure: Lesion Size
timeFrame: 3 months
measure: Physician Global Assessment (PGA)
timeFrame: 3 months
measure: Visual Analog Scale (VAS) for Pain
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: UCF Health Lake Nona Office
state: Florida
Study officials:
References:
Clinical trial NCT00613379: PRO 140 by IV Administration in Adults With HIV-1 Infection
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of PRO 140 by Intravenous Administration in Adult Subjects With Human Immunodeficiency Virus Type 1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
treatment naïve
Lead sponsor: CytoDyn, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2008-02-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
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:

1. To assess and characterize the PK and PD of PRO 140 administered IV
2. To assess the antiviral activity of PRO 140
3. To assess the safety and tolerability of PRO 140


Eligibility criteria: Inclusion Criteria:

1. Males \& females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
2. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
3. CD4+ T-lymphocyte cell count ≥ 300 cells/mm3 and no documented count \< or = 250 cells/mm3
4. Has not taken any anti-retroviral therapy (ART) w/in 12 wks of Early Screening Visit
5. Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
6. Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit \& a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, \& be non-lactating. Male \& female subjects must agree not to participate in a conception process from Early Screening Visit through Day 59.

Exclusion Criteria:

1. CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
2. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
3. History of active hepatitis within the previous 24 wks
4. Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, experimental or approved.

Primary outcomes:
measure: Maximum Change in Viral Load Following Initiation of Treatment.
timeFrame: 59 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Stephen Morris, MD, PhD
role: STUDY_DIRECTOR
References: