louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01013350: Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants Who Have Participated in Cladribine Clinical Trials
Official title: Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in Cladribine Clinical Studies (PREMIERE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Cladribine
PREMIERE
Observational study
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2009-11-13
Enrollment: 1161
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Multiple Sclerosis and had already participated in Sponsor oral cladribine clinical development trials

Brief summary: Prospective Observational Long-term Safety Registry of Multiple Sclerosis Participants who Have Participated in Cladribine Clinical Trials


Eligibility criteria: Inclusion Criteria:

* Prior enrollment into selected oral cladribine clinical trials as of randomization to either study drug or placebo, once participation in the clinical trial has ended
* Written informed consent was given

Exclusion Criteria:

* Participants who cannot be reached by telephone
* Participants unable to answer the registry questionnaires and who do not have a next of kin or caregiver able to answer the registry questionnaires
* Participants who - either during the lag interval or subsequently enter an interventional study

Primary outcomes:
measure: Number of Participants With Serious Adverse Drug Reactions (SADRs)
timeFrame: up to 3251 days
measure: Time to Resolution of Lymphopenia, Among Registry Participants With Persistent Lymphopenia
timeFrame: up to 3251 days
measure: Number of Participants With Adverse Events (AEs) in the "Blood and Lymphatic System Disorders" System Organ Class (SOC) and in the "Neoplasms Benign, Malignant, and Unspecified" SOC
timeFrame: up to 3251 days
Secondary outcomes:
measure: Number of Participants With Pregnancy Outcomes
timeFrame: up to 3251 days
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Outcome Sciences, Inc
state: Massachusetts
Study officials:
affiliation: EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Giovannoni G, Galazka A, Schick R, Leist T, Comi G, Montalban X, Damian D, Dangond F, Cook S. Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety. Drug Saf. 2020 Jul;43(7):635-643. doi: 10.1007/s40264-020-00948-x.
Clinical trial NCT00225550: A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid Tumors
Official title: Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Daily for 5 Consecutive Days by Intravenous Infusion in Subjects With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX 01 003)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Neoplasms
Keywords: Cancer;
Tumors;
Neoplasms;
Anticarcinogenic Agents;
Antineoplastic Agents;
Cadherins
Lead sponsor: Adherex Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.


Eligibility criteria: Inclusion criteria:

* Signed written informed consent
* Male and female patients \> or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists
* Clinically or radiologically documented measurable disease.
* Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue
* Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)

Exclusion criteria:

* Receipt of ADH-1 prior to this clinical study
* Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry
* History of primary brain tumors or brain metastases
* History of spinal cord compression or tumors that have shown any evidence of active bleeding within 30 days before study entry.
* Stroke, major surgery, or other major tissue injury within 30 days before study entry
* History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
Study officials:
References:
Clinical trial NCT00154050: High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Occlusive Diseases
Keywords: restenosis
intima hyperproliferation
stent angioplasty
pain-free walking distance
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to test the hypothesis that high dose candesartan treatment compared to quinapril is able to reduce intima hyperproliferation and the restenosis rate after stent angioplasty in peripheral occlusive artery disease.

Detailed description: Patients are randomly assigned to treatment with either candesartan 32 mg/d or Quinapril 20 mg/d before the angioplasty. Walking distance, intima media thickness and crurobrachial pressure ratios are compared after 6 weeks, 3 months and 6 months. After 6 months an angiographic control is performed.

Eligibility criteria: Inclusion Criteria:

* male and female
* peripheral occlusive arterial disease Stad IIb Fontaine classification

Exclusion Criteria:

* patients with lesions not available for PTA
* renal insufficiency
* patients on calcium-antagonists

Primary outcomes:
measure: Restenosis/reintervention after 6 months
Secondary outcomes:
measure: pain-free walking distance
measure: crurobrachial pressure ratios
Other outcomes:
Locations:
city: Chemnitz
country: Germany
facility: Chemnitz Hospital, Dept. of Internal Medicine I
Study officials:
affiliation: Institute of Clinical Pharmacology
name: Wilhelm Kirch, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02178150: Effect of Magnesium Supplementation on Polycystic Ovary Syndrome
Official title: Effect of Magnesium Supplementation on Metabolic Profile and Sex Hormone Levels in Overweight Women With Polycystic Ovary Syndrome.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Magnesium
Insulin Resistance
Lipid profile
Sex hormones
Inflammatory factors
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a double-blind randomized clinical trial which will start at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size calculated 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including sex hormone levels, metabolic and inflammatory profiles will be measured at the beginning and end of the study as well as anthropetric measurements.


Eligibility criteria: Inclusion Criteria:

* Having PCOS according to the Rotterdam criteria,
* Age between 20-45 years,
* Lack of pregnancy and lactation,
* Not having certain regime during last 3 months,
* Non-smoking,
* Not having diseases, including: diabetes, cardiovascular , hepatic, renal and thyroid,
* Not taking supplements,
* Being overweight (Kg / m 25 ≤ BMI)

Exclusion Criteria:

* Hormone Therapy,
* Pregnancy and lactation during the study,
* Severe weight loss (more than 2.5 kg per month) during the study

Primary outcomes:
measure: Serum insulin level
timeFrame: 8 Weeks
Secondary outcomes:
measure: Insulin Resistance
timeFrame: 8 weeks
measure: Fasting Blood Sugar
timeFrame: 8 weeks
measure: Quantitative insulin sensitivity check index (Quicki)
timeFrame: 8 weeks
measure: HOMA-IR
timeFrame: 8 weeks
measure: HOMA-B
timeFrame: 8 weeks
measure: High Density Lipoprotein
timeFrame: 8 weeks
measure: Low Density Lipoprotein
timeFrame: 8 weeks
measure: Triglyceride
timeFrame: 8 weeks
measure: Total Cholesterol
timeFrame: 8 weeks
measure: Androgen
timeFrame: 8 weeks
measure: Testosterone
timeFrame: 8 weeks
measure: C-Reactive Protein
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Ahmad Esmaeilzadeh, professor
role: STUDY_CHAIR
References:
citation: Farsinejad-Marj M, Azadbakht L, Mardanian F, Saneei P, Esmaillzadeh A. Clinical and Metabolic Responses to Magnesium Supplementation in Women with Polycystic Ovary Syndrome. Biol Trace Elem Res. 2020 Aug;196(2):349-358. doi: 10.1007/s12011-019-01923-z. Epub 2020 Jan 20.
Clinical trial NCT06951750: Effect of Foot Reflexology on Postpartum Afterpains
Official title: Effect of Foot Reflexology on Postpartum Afterpains
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain, Labor
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 36
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to determine the effect of foot reflexology on afterpains after normal labor.

Detailed description: Afterpains are among the most prevalent complaints after natural vaginal delivery. Non-pharmacological treatment modalities to relieve afterpains are an important care priority as they can lead to maternal and neonatal complications including anxiety, sleep disturbances, emotional disorders, depression, inability to care for the baby and continue breastfeeding, delays in early breastfeeding, reduced maternal ability to perform daily chores.

It was reported that pain in the early hours postpartum is one of the most important factors contributing to chronic postpartum pain and depression. Furthermore, pain and stress increase adrenaline release and decrease oxytocin release, thus leading to the cessation of the oxytocin reflex and disrupting breast milk production in addition to causing discomfort for the mother.

Since afterpains is a common problem that affects the physical and mental well-being of mothers, it requires the attention of healthcare providers. There is only one study that investigated the effect of reflexology on the pain level of afterpains after normal vaginal delivery. Moreover, no study investigated the effect of reflexology on either the behavioral response toward pain or the pressure pain threshold. Therefore, this study will be conducted to provide physiotherapists with updated scientific Knowledge concerning the effect of foot reflexology on afterpains after normal labor. This Study may expand the role of physiotherapy in women's health.

Eligibility criteria: Inclusion Criteria:

* They will be multipara (2-3).
* They will be normal vaginal labor

Exclusion Criteria:

* High-risk pregnancy.
* Post-partum hemorrhage.
* Neonatal birth weight over 4 kg.
* Over distension of the uterus.
* Cesarean section.

Primary outcomes:
measure: Assessment of pain intensity
timeFrame: 4 hours
measure: Modified version of chamber price pain Rating Scale
timeFrame: 4 hours
measure: Pressure pain threshold (PPT):
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hala Ismail Mahmoud
Study officials:
affiliation: Cairo University
name: Hazem El-Ashmawy, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Doaa Osman, As professor
role: STUDY_CHAIR
References:
Clinical trial NCT03869450: A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers
Official title: A Multi-center, Evaluator-blinded Study to Evaluate Effectiveness and Safety of HA Fillers for Lifting, Contouring and Correcting Volume Deficiency of the Midface Using an Individualized Treatment Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volume Deficiency of the Midface
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-03-11
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate the degree of improvement in appearance after treatment with different hyaluronic acid (HA) fillers. Product selection is based on Investigator assessment of participant tissue coverage and main treatment goal (volumizing, lifting or contouring).


Eligibility criteria: Inclusion Criteria:

* Male/Female 25 to 55 years old that needs lifting, contouring or volumization of the midface
* Signed and dated informed consent

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel and lidocain
* Previous use of any permanent or semi-permanent facial tissue augmentation therapy or contouring with, lifting threads, permanent implants, or autologous fat in the treatment area
* Previous use of any HA or collagen based facial tissue augmentation therapy in the facial area, any previous use of neurotoxin or any previous facial surgery
* Any medical condition that in the opinion of the Investigator would make the participant unsuitable for inclusion

Primary outcomes:
measure: Percentage of Participants With Aesthetic Improvement of Midface
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of Participants With Improved Midface Volume
timeFrame: 8 weeks
measure: Percentage of Participants Assessed as Having Natural Treatment Results
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Galderma Research Site
city: Palermo
country: Italy
facility: Galderma Research Site
city: Edinburgh
country: United Kingdom
facility: Galderma Research Site
Study officials:
affiliation: Galderma R&D
name: Q-Med AB
role: STUDY_DIRECTOR
References:
Clinical trial NCT00944450: Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
Official title: An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of Tablet Formulations Containing the Anhydrous and Monohydrate (FMI) Forms of MK0431
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Female subjects must have a negative pregnancy test
* Subject is within 30% of ideal body weight
* Subject does not smoke
* Subject agrees to follow the study guidelines

Exclusion Criteria:

* Subject has a history of any illness that might confound the results of the study or make participation unsafe for the subject
* Subject has a history of hypoglycemia
* Subject has a history of any hepatic disease
* Subject is taking any oral, parenteral, topical or implantable contraceptives

Primary outcomes:
measure: Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
timeFrame: Through 72 Hours Following the Administration of the Medication
measure: Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
timeFrame: Through 72 Hours Following the Administration of the Medication
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03998150: Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study
Official title: Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPH With Urinary Obstruction
Male
Keywords: BPH
enucleation
Prostate
LUTS
IPSS
quality of life
Large prostate
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Theodor Bilharz Research Institute
First posted: 2019-06-26
Enrollment: 64
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.

Detailed description: To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (\>80gm).

Eligibility criteria: Inclusion Criteria:

* Patients suffering from LUTS secondary to infravesical obstruction from BPH
* failed medical treatment
* International Prostate Symptom Score (IPSS) \> 13
* a peak urinary flow rate (Qmax) \< 15 ml/sec
* a prostate size ≥ 80 gm

Exclusion Criteria:

* presence of a urethral stricture
* neurological disorder
* bladder cancer
* prostate cancer
* previous history of bladder neck surgery or TURP

Primary outcomes:
measure: hemoglobin drop postoperatively (gm/dL)
timeFrame: Immediate postoperatively
measure: operative time
timeFrame: during surgery
Secondary outcomes:
measure: complications (%)
timeFrame: one year
measure: urine flow
timeFrame: one year
measure: post-voiding residual urine
timeFrame: one year
measure: International prostate symptom score (IPSS)
timeFrame: one year
measure: Quality of life (QoL) section of International prostate symptom score (IPSS)
timeFrame: one year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Cairo University
name: enmar I Habib, Prof.
role: STUDY_DIRECTOR
References:
citation: Habib E, Ayman LM, ElSheemy MS, El-Feel AS, Elkhouly A, Nour HH, Badawy MH, Elbaz AG, Roshdy MA. Holmium Laser Enucleation vs Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: A Randomized Controlled Trial. J Endourol. 2020 Mar;34(3):330-338. doi: 10.1089/end.2019.0707. Epub 2020 Feb 28.
Clinical trial NCT01914055: Dissecting the Role of Distal Embolization of Athero-thrombotic Material in Primary PCI: the ThrombOticBurden and mIcrovAscularobStruction (TOBIAS) Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 20
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: demonstrate that FD-OCT guidance is feasible and possibly results in reduction of frequency-domain Optical Coherence Tomography-defined residual thrombus burden after thrombus-aspiration.


Eligibility criteria: Inclusion Criteria:

* ST elevation myocardial infarction
* Ages Eligible for Study: \>18 years old
* Genders Eligible for Study: Both (female sex with child-bearing potential excluded)

Exclusion Criteria:

* occluded (TIMI 0) or sub occluded (TIMI 1) proximal vessel of estimated diameter ≥3mm
* intended use of thrombus aspiration

Primary outcomes:
measure: number of cross-sections with thrombus area more than 10% at post-stenting frequency-domain (FD) Optical Coherence Tomography
timeFrame: within the primary PCI procedure
Secondary outcomes:
measure: major adverse cardiac events
timeFrame: at 6 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Cardiovascular Department, Ospedale S.Donato
state: AR
Study officials:
References:
Clinical trial NCT06282055: Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes
Official title: Trajectories in Insulin Sensitivity Across Menstrual Cycles in Women With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus, Type 1
Keywords: Menstrual cycle
Trajectories
Women
Insulin sensitivity
Lead sponsor: DCB Research AG
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with menstrual cycles living with Type 1 Diabetes who are using a hybrid closed-loop system.

Brief summary: Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.


Eligibility criteria: Inclusion Criteria:

* Living with Type 1 Diabetes
* Perimenopausal people with menstrual cycle
* Using a hybrid closed-loop system
* Signed digital informed consent

Exclusion Criteria:

* Using hormonal therapy or contraception

Primary outcomes:
measure: Identify different trajectories of insulin sensitivity throughout the menstrual cycle
timeFrame: 6 months
Secondary outcomes:
measure: Total daily Insulin dose throughout the menstrual cycle
timeFrame: 6 months
measure: Coefficient of glucose variability throughout the menstrual cycle
timeFrame: 6 months
measure: Estimated insulin sensitivity throughout the menstrual cycle
timeFrame: 6 months
measure: Glycaemic profile (mean glucose, time in range, time above range, time below range, coefficient of variability) throughout the menstrual cycle
timeFrame: 6 months
measure: Correlations between insulin sensitivity trajectories and confounders
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: