louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04227171: Observational Study to Develop Dosing Chart
Official title: A Multicenter, Prospective Cohort Observational Study to Develop Dosing Chart Based on Patient Specific Characteristics and Ovarian Response When Follitrope™ PFS is Administered Subcutaneously to Infertility Women Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertile Women Undergoing IVF or ICSI
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 534
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile women undergoing In vitro fertilization(IVF) or Intracytoplasmic sperm injection (ICSI) for controlled ovarian stimulation

Brief summary: To confirm the predictors based on patient specific characteristics and ovarian response and develop dosing chart when Follitrope™ PFS is administered to infertility women patients.


Eligibility criteria: Inclusion Criteria:

* Female aged of 19 to 39 years
* Mean menstrual cycle in 25 to 35 days
* Patients to whom Follitrope PFS will be administered in those scheduled to undergo the IVF-ET according to the GnRH agonist or antagonist protocol
* In the past continuous IVF cycle failure less than 2 times

Exclusion Criteria:

* Patients having a history of ovarian, breast, uterus, hyperthalamus, or pituitary tumor
* Abnormal uterine bleeding of undetermined origin
* Prior hypersensitivity to a component of recombinant FSH
* Ovarian cyst or enlargement of undetermined origin
* Clinically significant endocrine abnormalities
* Patients having polycystic ovary syndrome (PCOS) history
* Poor Ovarian responder (Bologna criteria)
* Patients who received Clomiphene citrate, Letrozole (Pemara), or Gonadotropin within 30 days prior to enrollment in this study

Primary outcomes:
measure: No. of oocytes retrieved No. of oocytes retrieved Number of oocyte retrieved
timeFrame: after OPU, normally 2 weeks
Secondary outcomes:
measure: Oocyte maturity quality
timeFrame: after OPU, normally 2 weeks
measure: Total dose (IU) of Follitrope™ PFS administered
timeFrame: 2 weeks
measure: Total duration (days) of Follitrope™ PFS administered
timeFrame: 2 weeks
measure: E2 concentration on hCG day
timeFrame: normally 10 days
measure: P4 concentration on hCG day
timeFrame: normally 10 days
measure: Fertilization rate
timeFrame: 1~2 days after OPU
measure: Number of embryo transferred
timeFrame: 3~5 days after OPU
measure: Implantation rate
timeFrame: 24 days after OPU
measure: Biochemical pregnancy rate
timeFrame: 10 days after OPU
measure: clinical pregnancy rate
timeFrame: 24 days after OPU
measure: pregnancy rate
timeFrame: up to 10 weeks after OPU
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Maria Fertility Hospital
Study officials:
References:
Clinical trial NCT00176371: Improvement of Physical Activity and Correction of Body Mass Index in School Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Overweight
Keywords: Physical fitness
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is an increasing incidence of overweight children in Germany, due to a lack of physical activity.

The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year.

Detailed description: The increasing incidence of overweight children in Germany is due to a lack of physical activity and intake of unhealthy food. The importance of physical activity for the prevention of cardiovascular diseases in adults was shown in several trials. Therefore we provide additional sport lessons over the period of one year in two defined schools in Leipzig with the aim to improve physical fitness in school children. Two other classes with the -in germany- usual quantity of sport classes served as control classes.

In all classes at the beginning and at the end of the school year blood samples were taken, and a clinical investigation, a coordination test for children and a spiroergometer were performed. Additionally each child had to fill out a questionnaire.

Endurance training is emphasized in the sport lessons.

Eligibility criteria: Inclusion Criteria:

* School class

Exclusion Criteria:

* Condition precluding exercise

Primary outcomes:
measure: Improvement of maximal oxygen uptake
Secondary outcomes:
measure: Change in body mass index
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Gerhard Schuler, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walther C, Mende M, Gaede L, Muller U, Machalica K, Schuler G. [Effects of daily physical exercise at school on cardiovascular risk--results of a 2-year cluster-randomized study]. Dtsch Med Wochenschr. 2011 Nov;136(46):2348-54. doi: 10.1055/s-0031-1292049. Epub 2011 Nov 8. German.
citation: Walther C, Gaede L, Adams V, Gelbrich G, Leichtle A, Erbs S, Sonnabend M, Fikenzer K, Korner A, Kiess W, Bruegel M, Thiery J, Schuler G. Effect of increased exercise in school children on physical fitness and endothelial progenitor cells: a prospective randomized trial. Circulation. 2009 Dec 1;120(22):2251-9. doi: 10.1161/CIRCULATIONAHA.109.865808. Epub 2009 Nov 17.
Clinical trial NCT01281371: Observation Study of the Medication Switch at Patients Treated With Sitaxentan to a Regime Without Sitaxentan
Official title: Clinical Devolution of a Medication Change at Patients With Mono- or Combination Therapy With Sitaxentan to a Regime Without Sitaxentan.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Pulmonary
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-01-21
Enrollment: 9
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 treated with Sitaxentan

Brief summary: Due to the withdrawal of Thelin (Sitaxentan) in December 2010 all patients with pulmonary hypertension treated with Sitaxentan need to be switched to an alternative therapy. This study will observe in which way the change of medication - in the clinical routine, without exception in charge of the treating physician - affects clinical and laboratory parameters and patient's quality of life.


Eligibility criteria: Inclusion Criteria:

* Pulmonary hypertension
* Treatment with Sitaxentan

Exclusion Criteria:

* Inability or unwillingness to give written informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Clinical Pharmacology and Pharmacoepidemiology, Medical department of the University of Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Department of Clinical Pharmacology and Pharmacoepidemiology
name: Walter E. Haefeli, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05856071: TEL and Clam Shell Exercises Affect After ACL
Official title: Effects of Clamshell Exercises in Terminal Extension Lag After Anterior Cruciate Ligament
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Ligament Injury
Keywords: anterior cruciate ligament reconstruction
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study to determine the effects of the addition of isolated hip strengthening exercises to traditional rehabilitation after Anterior cruciate ligament reconstruction (ACLR). Clamshells exercises unique in scene because it mainly focuses on the muscle surrounding the hip whereas the traditional exercises mostly paid attention on quads and hams exercise

Detailed description: In 2020, researcher conducted a randomized controlled clinical trial to determine "Does six-weeks of Hip-focused exercises has the effects on Time to Stabilization after Anterior Cruciate Ligament Reconstruction". The purpose of these study to determine the relationship between muscle strength and time taking to increase the performance of knee. The main findings suggesting that rehabilitation program targets on strengthen the hip muscles in comparison with traditional exercises of knee demonstrate an improvement of knee functions in individual with Anterior cruciate ligament reconstruction (ACLR).

In previous studies there is very less literature regarding determining effects of the clamshells exercises on extension lag after anterior cruciate ligament reconstruction. Therefore there is a dire need to explore the effect of the clamshells exercises on post anterior cruciate ligament reconstruction extension lag. This study aims in the management of pain disability and functional impairment in persons with extension lag with clamshells exercises after ACL reconstruction.

Eligibility criteria: Inclusion Criteria:

* Age 20-40
* Both Genders (male \& female)
* History of Anterior Cruciate Ligament Reconstruction (ACLR) between 1-3 years

Exclusion Criteria:

* Any other previously serious knee pain and/or surgery.
* Limiting of knee range of motion.
* Any traumatic conditions around the knee, or any infectious or tumors conditions
* Pregnancy, any recently underwent abdominal and back surgery.

Primary outcomes:
measure: extension knee range of motion
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Imran
state: Punjab
Study officials:
affiliation: Riphah International University
name: Rabiya Noor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01733771: The Effect of Complementary Medicine (CAM) Treatments on Common Symptoms in Hospitalized Patients
Official title: Patient Reported Outcomes Following Complementary Medicine Treatments in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Nausea
Anxiety
Keywords: complementary medicine
hospitalized
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-11-27
Enrollment: 300
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: This is a randomized, single blinded, interventional trial conducted in patients undergoing elective laparoscopic cholecystectomy, comparing the following three groups: Controls receiving standard-of-care (SoC) only (Group 1); intervention group receiving reflexology and SoC (Group 2); and a group receiving sham reflexology and SoC (Group 3). In all groups, level of preoperative anxiety was evaluated at entry and exit from the Holding Room Area (HRA). The evaluation was carried out using the Visual Analogue Scale for Anxiety (VAS-A) questionnaire.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years
2. Undergoing Laparoscopic Cholecysyectomy (LC)

Exclusion criteria:

1. Patients with a history of obstructive sleep apnea
2. Contraindication for benzodiazepines
3. Hemodynamic instability
4. Leg ulcers
5. Patients undergoing a LC together with another surgical procedure.

Primary outcomes:
measure: Perioperative Anxiety Expressed in Visual Analogue Scale for Anxiety (VAS-A) From 0 (Asymptomatic: no Anxiety) to 10 Extremely Symptomatic Anxiety
timeFrame: Baseline and 4 hours post treatment: calculated as value at 4 hours post treatment minus value at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Director, Internal Medicine B
name: Elad Schiff, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiff E, Attias S, Matter I, Sroka G, Nae B, Arnon Z, Samuels N, Grinberg O, Ben-Arye E. Complementary and alternative medicine interventions for perioperative symptoms: A comparative effectiveness study. Complement Ther Med. 2019 Jun;44:51-55. doi: 10.1016/j.ctim.2019.03.003. Epub 2019 Mar 21.
Clinical trial NCT02095171: Single Ascending Dose Study of PRX002 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Prothena Biosciences Limited
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2014-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX002 in approximately 40 healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Body mass index (BMI) between 18-32 kg/m2 with a minimum weight of 46 kg
* Female subjects must be surgically sterile or post-menopausal or if of child-bearing potential must use contraception
* Male subjects and their partners of childbearing potential must use contraception

Exclusion Criteria:

* Positive test for drug of abuse
* Past or current history of alcohol abuse
* Positive for hepatitis B, hepatitis C or HIV infection

Primary outcomes:
measure: Safety and tolerability as determined by number of subjects with adverse events
timeFrame: up to 3 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 3 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 3 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 3 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 3 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 3 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 3 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 3 months
measure: Determination of pharmacokinetics parameters
timeFrame: up to 3 months
Secondary outcomes:
measure: Immunogenicity as determined by measurement of anti-PRX002 antibodies
timeFrame: up to 3 months
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Clinical Trials Prothena Biosciences Inc
name: Theresa Neumann, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04292171: Gabapentin for Perioperative Pain Relief in Surgical Abortion
Official title: Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain Control
Keywords: Gabapentin Abortion
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 219
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind placebo-controlled randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.

Detailed description: A double-blind placebo controlled trial of gabapentin in the setting of an ambulatory surgical abortion center where patients receive either the routine intravenous sedation, local cervical anesthesia plus 600mg of gabapentin one hour prior to surgery vs. the same regimen plus placebo one hour prior to surgery. Our primary outcome measure will be post-operative validated pain scores using a 11-point visual analog scale (VAS). Secondary measures will include nausea and vomiting during, after and 24 hours after the procedure. A second and third pain assessment using VAS will be made at 30 minutes and at 24 hours postoperatively.

Eligibility criteria: Inclusion Criteria:

* Women seeking surgical abortion between 5 and 23 6/7 weeks of ultrasound age.
* English or Spanish speaking
* eligible for office-based surgical pregnancy termination

Exclusion Criteria:

* present use of gabapentin or pregabalin,
* renal disease
* sensitivity or allergy to gabapentin
* Missed abortion

Primary outcomes:
measure: Pain Score
timeFrame: 5 minutes postoperative
Secondary outcomes:
measure: Pain Score 24
timeFrame: 24 hours postop
measure: Nausea
timeFrame: 24 hours postoperative
measure: Vomiting
timeFrame: 24 hours postoperative
measure: Pain Score at 30 Minutes Postoperative
timeFrame: 30 minutes postoperative
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Birth Control Care Center
state: Nevada
Study officials:
affiliation: University of Nevada School of Medicine
name: Vani Dandolu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04955171: BEOVU Versus Eylea in the Treatment of Diabetic Macular Edema
Official title: Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Macular Edema
Keywords: BEOVU
Eylea
diabetic macular edema
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 60
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: Diabetic macular edema degeneration occur is a vision threatening condition. The investigators compare the efficacy of BEOVU and Eylea intravitreal treatment in the management

Detailed description: Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination was done. Procedure included randomized intravitreal injection of Brolucizumab(BEOVU®, Genentech, South Francisco, CA) and of aflibercept (Eylea;Regeneron, Tarrytown,NY)

Eligibility criteria: Inclusion Criteria:

* Diabetic macular edema

Exclusion Criteria:

* other causes of macular edema
* other macular diseases

Primary outcomes:
measure: Best corrected visual acuity (BCVA)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha University
name: TAREK ELHAMAKY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04476771: Cultivating Well-being in Subclinical Paranoia
Official title: Cultivating Well-being Beyond Symptomatology in Subclinical Paranoia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wellbeing
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The intervention is called Feliz-Mente, with third generation therapy components that aims to improve wellbeing and self-enhancement. Without intervening directly on the symptoms, it is expected to increase positive experiences, the use of personal strengths and positive relationships, and aims to build a more meaningful self-narrative in persons with subclinical paranoia. Feliz-Mente is a group intervention of 12 sessions in which participants are expected to perform exercises during and between sessions by the use of a mobile application to improve treatment adherence and daily practice. The design for the present study is a randomized controlled trial, which compares the post-intervention measures of the experimental group (group receiving the intervention and the daily use of a mobile application of the program) with the post-intervention measures of the control group (treatment as usual + waiting list).


Eligibility criteria: Inclusion Criteria:

* Participants between 18 and 35 years old
* At least two standard deviations above mean on the scales of distress, suspicion and /or interpersonal sensitivity in the SCL-90 questionnaire.

Exclusion Criteria:

* Participants with borderline personality disorder
* Participants with substance use disorders and /or
* Participants with severe cognitive impairment.

Primary outcomes:
measure: Change from Well-being at 12 weeks, 3 months and 12 months
timeFrame: Change baseline, 12 weeks, 3 months and 12 months
measure: Change from Well-being at 12 weeks, 3 months and 12 months
timeFrame: Change baseline, 12 weeks, 3 months and 12 months
Secondary outcomes:
measure: Change from Well-beingDistress at 12 weeks, 3 months and 12 months
timeFrame: Change baseline, 12 weeks, 3 months and 12 months
measure: Change from self-esteem at 12 weeks, 3 months and 12 months
timeFrame: Change baseline, 12 weeks, 3 months and 12 months
measure: Change from self-esteem at 12 weeks, 3 months and 12 months
timeFrame: Change baseline, 12 weeks, 3 months and 12 months
measure: Change from Attachment at 12 weeks, 3 months and 12 months
timeFrame: Change baseline, 12 weeks, 3 months and 12 months
measure: Change from Paranoid ideation at 12 weeks, 3 months and 12 months
timeFrame: Change baseline, 12 weeks, 3 months and 12 months
measure: additional Outcome Measures Experience of trauma events
timeFrame: baseline
Other outcomes:
Locations:
city: Pozuelo de Alarcón
country: Spain
facility: Carmen Valiente
state: Madrid
Study officials:
References: