louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06768411: The Dosage Exploration Study of PEG-rhGH for Treating Short Stature in Prepubertal and Pubertal Children
Official title: The Dosage Exploration Study of PEG-rhGH for Treating Short Stature in Prepubertal and Pubertal Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Short Stature
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is dedicated to addressing the lack of research on the most effective dosage of long-acting growth hormone for children with short stature. By employing clinical trial design, we are committed to investigating the therapeutic benefits and safety profiles associated with varying doses of long-acting growth hormone. Our ultimate goal is to offer clinicians more precise treatment guidance and assist patients in attaining optimal growth and developmental outcomes.


Eligibility criteria: Inclusion Criteria:

1. Patients with short stature or a genetic target height below 2 standard deviations;
2. Individuals who are pre-pubertal (Tanner stage I) and pubertal (Tanner stages II-IV).
3. Legal guardians consenting to participate in the study and signing informed consent forms.

Exclusion Criteria:

1. Known or suspected hypersensitivity reactions to the investigational product or related products;
2. Presence of severe systemic diseases;
3. Patients with malignant tumors;
4. Participation in any other clinical trial and receipt of drug or non-drug interventions within the 3 months prior to screening;
5. Patients unable to adhere to follow-up or receive treatment as scheduled;
6. Other circumstances in which the investigator deems the patient unsuitable for inclusion in this clinical trial.

Primary outcomes:
measure: height growth rate
timeFrame: 2 years
Secondary outcomes:
measure: Sexual development status
timeFrame: two years
measure: IGF-1
timeFrame: two years
Other outcomes:
measure: bone age
timeFrame: 2 years
Locations:
Study officials:
References:
Clinical trial NCT01017211: Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?
Official title: Does Auricular Acupuncture Improve Tolerance to Electromyography (EMG) Testing?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Pain
Electromyography
Acupuncture
Randomized controlled trial
Rehabilitation
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Needle Electromyography (EMG) is an important test used to assess muscle and nerve function, but the test can be uncomfortable. It is currently not standard practice to provide any pain-relieving intervention for this procedure. The purpose of this research study is to determine whether auricular (ear) acupuncture will make EMG testing less painful.


Eligibility criteria: Inclusion Criteria:

* Gender: male or female
* Of any racial or ethnic group
* Adult between the ages 18 to 65 years
* Healthy
* Normal sensation and strength
* Pain approximately the same on each side of body with no major difference between right and left sides
* Can understand and are able to complete the outcomes questionnaires which will be explained before the study protocol begins

Exclusion Criteria:

* Pregnant or actively trying to become pregnant
* Diabetes mellitus or other systemic disease which may affect nerve function
* History of a neurologic disorder or other cause for abnormal sensation or weakness
* Have had recent trauma to an upper arm, hand or ear
* Have scars or burns on an upper arm, hand or ear that causes abnormal or decreased sensation
* Taking pain medications on a regular basis
* Have a bleeding or clotting disorder
* Taking blood thinners, such as aspirin, heparin, enoxaparin (Lovenox), clopidogrel (Plavix) or coumadin (Warfarin)
* Have received chemotherapy or radiation
* Have a permanent pacemaker
* Have a serious psychiatric disorder (such as schizophrenia)
* More sensitive to pain on one side of my body more than the other

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: pre- and post- intervention
Secondary outcomes:
measure: Global Impression of Change
timeFrame: pre- and post- intervention
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
Study officials:
affiliation: Kessler Institute for Rehabilitation
name: Jeff Cole, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01933893: Follicular Versus Luteal Pipelle in Repeated Implantation Failure Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Repeated Implantation Failure
Keywords: Pipelle, luteal, follicular, implantation
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-09-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women diagnosed with repeated implantation failure (RIF) who are undergoing IVF treatment.

Brief summary: Pipelle was found to increase pregnancy and implantation rates in women undergoing IVF treatment in general, and in particular in repeated implantation failure (RIF). However, there is virtually no data regarding the optimal timing for the pipelle.

The current study aims to compare between follicular and luteal pipelle on pregnancy rate in RIF patients.


Eligibility criteria: Inclusion Criteria:

Women diagnosed with RIF who are going to start a new IVF treatment

Exclusion Criteria:

Known hydrosalpinx body mass index (BMI) \>29 kg/m2 or \<18 kg/m2 Low ovarian response

Primary outcomes:
measure: Pregnancy rate
timeFrame: April, 2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assaf Harofeh Medical Center, Zerifin, Israel
name: Ido Ben-Ami, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01105793: An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate to Severe Cyclic Mastalgia
Keywords: cyclic mastalgia
cyclic breast pain
fibrocystic breast disease
Lead sponsor: FemmePharma Global Healthcare, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.


Eligibility criteria: Inclusion Criteria:

* menstruating females at least 18 years of age
* BMI less than 30
* moderate to severe breast pain associated with the menstrual cycle
* in good general health

Exclusion Criteria:

* pregnant within the last 6 months
* has taken in the last 3 months or currently taking hormonal contraception
* history of malignancy or currently being treated for cancer of the breast or genital organs
* has had breast implants or breast reduction surgery

Primary outcomes:
measure: Reduction in breast pain
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Women's Health Care
state: California
city: Denver
country: United States
facility: Horizons Clinical Research
state: Colorado
city: Lexington
country: United States
facility: Kentucky Medical Research Center
state: Kentucky
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
Study officials:
References:
Clinical trial NCT00005493: Observational Aspirin Use and CVD in the Physicians' Health Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Cerebrovascular Accident
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To analyze existing data from the Physicians Health Study (PHS), a randomized primary prevention trial of low-dose aspirin and beta carotene conducted among 22,071 U.S. male physicians, to address questions concerning aspirin and cardiovascular (CV) disease that could not adequately be addressed during the randomized aspirin period.

Detailed description: DESIGN NARRATIVE:

The aspirin component of the trial was terminated on January 25, 1988, due to a demonstrated benefit of aspirin on myocardial infarction. At that time, however, the number of strokes and CV deaths experienced by trial participants was inadequate to definitively evaluate these endpoints. The beta carotene component of the trial continued uninterrupted until its scheduled termination in December, 1996. During this period detailed information continued to be collected on post-trial aspirin use through annual questionnaires. As of October, 1995, the number of deaths, including cardiovascular deaths, had increased fourfold from that in the randomized period, and the number of strokes had increased 3.5 times. The investigators used data from both the randomized aspirin period and the observational period following the trial to assess the impact of aspirin use on cardiovascular and total mortality, and the long-term impact of aspirin use on subsequent stroke and MI. The methods included analyses of both randomized aspirin assignment and of time-varying aspirin use, as assessed on the annual questionnaires. Because of the potential for bias, the propensity for aspirin use, particularly during the observational period was taken into account. Analyses included use of proportional hazards models allowing for both time-varying effects of aspirin use and controlling for time-varying confounders, as well as more complex procedures using causal modeling.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Nancy Cook
References:
citation: Cook NR, Hebert PR, Manson JE, Buring JE, Hennekens CH. Self-selected posttrial aspirin use and subsequent cardiovascular disease and mortality in the physicians' health study. Arch Intern Med. 2000 Apr 10;160(7):921-8. doi: 10.1001/archinte.160.7.921.
citation: Cook NR, Cole SR, Hennekens CH. Use of a marginal structural model to determine the effect of aspirin on cardiovascular mortality in the Physicians' Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1045-53. doi: 10.1093/aje/155.11.1045.
Clinical trial NCT01575093: Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2012-04-11
Enrollment: 25
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2 Capsule Endoscopy.

Detailed description: The preparation regimen used for the PillCam® Colon 2 procedure consists of several colon cleansing materials.

Different combinations of the above regimen were tested and evaluated for safety by monitoring of adverse events in multiple clinical studies, with more than 1000 subjects enrolled to date. No Serious Adverse Events related to the preparation were noted.

In this study, each subject will be required to undergo serum chemistry tests (blood tests) at several time points to evaluate the safety of the regimen.

No capsule ingestion is involved.

Eligibility criteria: Inclusion Criteria:

1. Subject is between 50 - 75 years of age.
2. Subject is healthy without any known disease, or any current symptoms of any disease or other abnormal condition.
3. Subject received an explanation about the nature of the study and agrees to provide written informed consent.
4. Subject has normal serum chemistry tests at baseline.

Exclusion Criteria:

1. Subject has any allergy or other known contraindication to the medications used in the study.
2. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
3. Subject has Type 1 or Type II Diabetes.
4. Subject has any condition which precludes compliance with study instructions.
5. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
6. Subject suffers from life threatening conditions.
7. Concurrent participation in another clinical trial using any investigational drug or device.

Primary outcomes:
measure: To evaluate the safety of a bowel preparation regimen comprised of Sulfate free Polyethylene glycol electrolyte lavage solution (SF-PEG) plus SUPREP oral sulfate solution as a "booster", in adult subjects.
timeFrame: Latest blood test conducted (i.e. 24 hours after suppository or seven days after procedure)
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
Study officials:
affiliation: Pinnacle Research Group, LLC
name: PANKAJ K. KASHYAP, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238093: Cardiorenal Syndrome in End-Stage Kidney Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End-stage Renal Disease
Cardiorenal Syndrome
Heart Disease
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-09-12
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: End-stage renal disease patients undergoing dialysis at the Hillel Yaffe Medical Center.

Brief summary: Cardiorenal Syndrome (CRS) is prevalent among end-stage renal disease (ESRD) patients. Recently, its prevalence is rising. There are several different clinical presentations of this syndrome. It has a high rate of morbidity and mortality.

The purpose of this study is to find the connection between the heart pathology and its effect on ESRD patients. This will aid in choosing the appropriate medical therapy for these patients, and hopefully, aid in increasing their quality of life, and decrease their morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* End-stage renal patients

Exclusion Criteria:

* Cancer patients

Primary outcomes:
measure: Heart Pathology Identification
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Noa Berar-Yanay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02117193: Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Exercise Performance in Humans.
Official title: Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Cardiorrespiratory, Neuromuscular and Hormonal Responses in Healthy Males.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Intake
Sleep Deprivation
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2014-04-17
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Although the effects of acute alcohol intake and sleep deprivation on exercise performance lacks evidence in the literature, in many situations, they occur simultaneously. Once the alcohol affects physiological processes, the processes that occur during sleep can be impaired, such as: suppression of GH release, action of neurotransmitters and neuromodulators in the CNS, changes in the proportion of sleep stages and may lead to suppression of REM sleep. These changes promote a significant functional impairment such as a reduction in alertness and modification in reaction time, which affects the performance of any activity of daily and professional life. However, the combined effects on the physical performance variables, such as aerobic and neuromuscular performance lack of evidence in the literature.

Detailed description: Ten subjects were randomized in four situations after familiarization and control situation: (1) alcohol intake combined with sleep normal; (2) alcohol intake combined with sleep deprivation; (3) placebo intake combined with sleep normal and (4) placebo intake combined with sleep deprivation.

Eligibility criteria: Inclusion Criteria:

- Physical active men

Exclusion Criteria:

* AUDIT questionnaire above 15 points
* Nocturnal Chronotype
* Skeletal muscle injuries in upper and lower limb
* Metabolic and cardiovascular disease

Primary outcomes:
measure: Aerobic Performance
timeFrame: After each sequence, up to 8 hours
measure: Neuromuscular Performance
timeFrame: After each sequence, up to 8 hours
measure: Biochemical Responses
timeFrame: After each sequence, up to 8 hours
Secondary outcomes:
measure: Hydration Status
timeFrame: After each sequence, up to 8 hours
measure: Profile of Mood States
timeFrame: 6 months
measure: Breath Alcohol
timeFrame: 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Exercise Research Laboratory
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Rodrigo Rodrigues, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04809493: Study Evaluating the Effect of Isonatremic Dialysis Treatment in Chronic Kidney Disease Patients on Dialysis
Official title: Evaluation of the Effect of Isonatremic (vs Conventional) Dialysis Treatment on the Control of Interdialytic Weight Gain in Chronic Kidney Disease Patients on Dialysis (Stage 5D)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Disease patient on dialysis (stage 5D)
Extracorporeal purification
Isonatremic dialysis
Sodium
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients issued from dialysis units (hospital, clinic, non profit dialysis centers)

Brief summary: Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on:

* control of interdialytic weight gain
* perdialytic tolerance in terms of adverse events occurring during all of the sessions of the study
* body composition and thirst measured monthly during the 4 months of follow-up.
* tolerance to treatment.


Eligibility criteria: Inclusion criteria:

* Chronic Kidney Disease patient on dialysis (stage 5D)
* With plasma sodium concentration between 130 and 140 mmol/L
* Anuric
* Patient dialysed with dialysis machine allowing isonatremic dialysis treatment

Exclusion criteria:

* Patient with plasma sodium concentration below 130 or above 140 mmol/
* Pacemaker

Primary outcomes:
measure: Change of interdialytic weight gain during treatment
timeFrame: 1, 2, 3 and 4 months after inclusion
Secondary outcomes:
measure: Perdialytic tolerance in terms of adverse events occurring
timeFrame: 1, 2, 3 and 4 months after inclusion
measure: Body composition
timeFrame: 1, 2, 3 and 4 months after inclusion
measure: Rate of Tolerance
timeFrame: 1, 2, 3 and 4 months after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH MONTPELLIER
name: Jean-Paul CRISTOL, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT05094193: Trocar-site Infiltration Versus TAP-block
Official title: Trocar-site Infiltration With Ropivacaine Versus Tranversus Abdominis Plane Block Following Laparoscopic Cholecystectomy: a Double-blinded, Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Keywords: Acute pain management
Ropivacaine
Trocar-site infiltration
TAP-block
Laparoscopic cholecystectomy
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: For symptomatic gall bladder disorders (cholelithiasis and cholecystitis), laparoscopic cholecystectomy (LC) has been considered as the gold standard treatment. However, these minimally invasive technique is associated with acute moderate pain during the 24 hours postoperative, which is routinely managed using opioids. The transversus abdominis plane (TAP) block has been used as part of a multimodal analgesia strategy. Besides, Wang et al found that TAP block is more effective than a conventional pain control, but not significatively different from another local incisional pain control that is port site infiltration.So, the aim of this study, is to compare the analgesic efficacy and safety of trocar-site infiltration with ropivacaine with ultrasound-guided TAP block following laparoscopic cholecystectomy when used as part of multimodal analgesia.


Eligibility criteria: Inclusion Criteria:

* BMI \< 30 kg/m2
* Scheduled for laparoscopic cholecystectomy
* ASA grade I, II and III

Exclusion Criteria:

* Bile duct exploration, insertion of a T-drain or patients with acute cholecystitis
* Conversion to open cholecystectomy or if the surgery exceeded 200 minutes
* Severe systemic disease
* Patients on analgesics for any reason
* History of allergy to local anesthetics
* An ongoing pregnancy
* Patient refusal

Primary outcomes:
measure: Acute postoperative pain
timeFrame: up to 24 hours
measure: Total opioid consumption
timeFrame: Day 1
Secondary outcomes:
measure: Length of hospital stay
timeFrame: up to 1 week
measure: postoperative nausea and vomiting
timeFrame: Day 1
measure: Patient satisfaction and quality of recovery
timeFrame: Day 1
measure: Incidence of shoulder pain
timeFrame: Day 1
measure: Postoperative complication
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Habib Thameur Hospital
Study officials:
affiliation: Habib Thameur Hospital of Tunis, Department of Anesthesia
name: BEN FADHEL Kamel, M.D
role: STUDY_DIRECTOR
References: