louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00040547: Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors (Study P01964)(COMPLETED)
Official title: Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Combination With Docetaxel in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Cancer-Advanced Solid Tumors
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2002-07-01
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of an oral Farnesyl Protein Transferase Inhibitor (SCH 66336) when given in combination with intravenous docetaxel in cancer patients with advanced solid tumors.


Eligibility criteria: Inclusion:

* Male or Female
* Measurable or evaluable disease
* No more than 2 prior chemotherapy regimens.
* Age greater than or equal to 18.
* Karnofsky Performance Status greater than or equal to 70%.
* Meets protocol requirements for specified laboratory values.
* No manifestations of a malabsorption syndrome.
* Written informed consent and cooperation of patient
* Appropriate use of effective contraception if of child-bearing potential.

Exclusion:

* Acute or chronic leukemia or multiple myeloma.
* Evidence of 2 or more active malignancies, expect for in situ or adequately treated basal or squamous cell skin cancer.

Primary outcomes:
measure: Adverse Events
measure: Laboratory Tests
measure: ECG
Secondary outcomes:
measure: Physical Exam
measure: Pharmacokinetics
measure: Tumor Response
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05447247: Clinical Study on Treatment of Neurogenic Bladder by Electroacupuncture on Ba Liao Point Under Ultrasound Guidance
Official title: Clinical Study on Treatment of Neurogenic Bladder by Electroacupuncture on Ba Liao Point Under Ultrasound Guidance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: To Investigate the Clinical Effect of Acupuncturing Ba Liao for Neurogenic Bladder Under the Guidance of Ultrasound
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 114
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore acupuncture under the premise of real-time, dynamic and accurate positioning of Ba liao point with ultrasound, observe the clinical efficacy of treating neurogenic bladder, clarify the essence of acupoints, and provide a new method for the standardization of acupuncture and moxibustion.


Eligibility criteria: Inclusion Criteria:

1. The diagnosis of neurogenic bladder conforms to the main points;
2. Symptoms and signs: patients with lower urinary tract dysfunction such as frequency of urination, urgency of urination, inadequacy of urine or retention of urine, urinary incontinence; Physical examination showed paresthesia in perineum and saddle area.
3. Auxiliary examination; Routine urine examination, B - ultrasonography of urinary system and urodynamic examination.
4. Indwelling catheter has been removed;
5. Conscious and able to accurately express symptoms and signs;
6. Patients who inform patients and their families of the research situation in detail and obtain their consent for treatment.

   -

Exclusion Criteria:

1. Lower urinary tract dysfunction caused by non-nervous system factors such as urethral calculi and organic obstruction;
2. patients with serious heart and lung diseases, liver and hematopoietic diseases and mental diseases;
3. patients with prostate cancer, urethral stricture, bladder neck fibrosis, interstitial cystitis, glandular cystitis and other diseases;
4. patients implanted with urethral stents or sacral nerve electrodes;
5. pregnant and lactation women;
6. Fear of acupuncture, needle-sickness and blood sickness. -

Primary outcomes:
measure: Urodynamic study
timeFrame: Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment
measure: Neurogenic bladder symptom score
timeFrame: Once every two weeks:Before treatment, two weeks after treatment, four weeks after treatment.followed up for 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT06960447: Nd:YAG vs Alexandrite Laser Treatment in Hidradenitis Suppurativa
Official title: Comparative Efficacy of Nd:YAG and Alexandrite Laser Treatments in Hidradenitis Suppurativa: A Split-Person, Non-Inferiority Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hidradenitis Suppurativa (HS)
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Split-person trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether Alexandrite laser treatment is non-inferior to Nd:YAG (neodymium-doped yttrium aluminum garnet) laser treatment of hidradenitis suppurativa (HS).


Eligibility criteria: Inclusion Criteria:

* Geisinger male or female patients with a diagnosis of hidradenitis suppurativa (all stages of disease)
* 12-75 years of age
* Not on concurrent systemic therapy (e.g., antibiotics, biologic therapies)
* Must have not used systemic therapies within 2 weeks of enrollment in study
* Able and willing to provide consent

Exclusion Criteria:

* Patients who cannot tolerate laser therapy
* Patients who cannot wear protective eyewear
* Patients who are pregnant

Primary outcomes:
measure: HiSCR50
timeFrame: 6 months
measure: HiSQOL
timeFrame: 6 months
Secondary outcomes:
measure: Pain VAS score
timeFrame: 6 months
measure: Pruritus numeric rating scale
timeFrame: 6 months
measure: Days free of disease in last 30 days
timeFrame: 6 months
measure: AN Count
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Geisinger Clinic
name: Mikael K Horissian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02779647: Play as a Method to Reduce Overweight and Obesity in Children.
Official title: Play as a Method to Reduce Overweight and Obesity in Children. Kids-Play Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Sleep Apnea in Obese Children
Studying Maternal and Family Factors That Cause Obesity in Children
Keywords: Overweight, obesity, play, physical activity, accelerometry.
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 98
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction Overweight and obesity are characterised by excess fat, which results in weight gain and is identified by the Body Mass Index (BMI). Studies show that overweight and obesity are the result of a complex interaction between genetic and environmental factors, which begins prenatally. Various studies have shown that physical exercise is an important component of weight loss programmes and that it also benefits the metabolic profile. Other authors have reported that greater weight loss is achieved by a programme that includes both diet and exercise, rather than either of these alone.

Aim The aim of this study is to analyse an intervention based on play as a means of improving the body composition of children with overweight or obesity.

Design / Method The design of the Kids-Play study is based on cases and controls. The study was conducted in Granada (Spain) The analysis sample of 98 children was divided into two groups: cases, consisting of 49 children, who participated in an intervention programme based on physical activity, play and nutritional advice (to both the child and the parents); and controls, another 49 children, who received only nutritional advice.


Eligibility criteria: Inclusion Criteria:

* Obese children that want participate in a voluntary way in the research and sign the informed consent.

Exclusion Criteria:

* Refused to participate
* Hormonal problems
* Age \< 8 or \>12 years
* Orthopaedic, respiratory
* Other problems

Primary outcomes:
measure: Children's body composition
timeFrame: 12 months
Secondary outcomes:
measure: The level of daily physical activity
timeFrame: 1 month
measure: Sleep apnea
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
citation: Sanchez-Lopez AM, Menor-Rodriguez MJ, Sanchez-Garcia JC, Aguilar-Cordero MJ. Play as a Method to Reduce Overweight and Obesity in Children: An RCT. Int J Environ Res Public Health. 2020 Jan 3;17(1):346. doi: 10.3390/ijerph17010346.
citation: Aguilar-Cordero MJ, Rodriguez-Blanque R, Leon-Rios X, Exposito Ruiz M, Garcia Garcia I, Sanchez-Lopez AM. Influence of Physical Activity on Blood Pressure in Children With Overweight/Obesity: A Randomized Clinical Trial. Am J Hypertens. 2020 Feb 22;33(2):131-136. doi: 10.1093/ajh/hpz174.
Clinical trial NCT04572347: National Nurses Health Cohort Study (NNHS): a Web-based Ambispective Cohort Study in China
Official title: National Nurses Health Cohort Study (NNHS): a Web-based Ambispective Cohort Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nurse Health
Keywords: psychophysical health
career development
stress
metabolic indexes
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 2000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from Peking University Third Hospital through cluster sampling.

Brief summary: The purpose of the current study was to build an ambispective cohort study of female nurses, based on existing physical examination and nurse work schedule data and a web-based questionnaire system, focusing on the effects of occupational, environmental, and lifestyle risk factors on the health of Chinese women.


Eligibility criteria: Inclusion Criteria:

* Female registered nurses, licensed practical nurses and/or midwives with informed consent are included in this study

Exclusion Criteria:

* student nurses
* training nurses

Primary outcomes:
measure: psychophysical health related events
timeFrame: From 2010 to 2022
measure: mental health
timeFrame: From 2020 to 2022
Secondary outcomes:
measure: sleep quality
timeFrame: From 2020 to 2022
measure: social support
timeFrame: From 2020 to 2022
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Baohua Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhuo L, Zhang H, Geng R, Wang P, Zeng L, Che Y, Wang P, Li P, Huang T, Li B, Zhan S. Protocol for the National Nurse Health Study (NNHS): a web-based ambispective cohort study. BMJ Open. 2021 Aug 19;11(8):e049958. doi: 10.1136/bmjopen-2021-049958.
Clinical trial NCT02442947: Examination of Textile Solutions for Reducing Physiological Stress
Official title: Physiological Examination of Textile Solutions for Stress Reduction When Dressed in Protective Garment and Work Clothes and Under Physical and Heat Stress Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Stress
Keywords: stress when dressed
protective garment
work clothes
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-05-13
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Using protective or combat garments under heavy heat stress conditions, during rest or exertion, may hinder the body's ability to effectively exchange heat with the environment and thereby can lead to heat injuries. The purpose of this research is to physiologically examine the new textile solutions that are planned to be integrated in the protective garments, combat garments and work uniforms in the army, by evaluating the physiological stress obtained during exertion under hot climatic conditions.

Detailed description: 10 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination which includes ECG, anthropometric measurements and Vo2max test. Afterwards, the subjects will perform 6 acclimatization days carried out by the standard protocol of Heat Tolerance Test (HTT). After acclimatization, the subjects will undergo 4 experiment days under heavy heat stress in a climatic chamber, dressed in each experiment day with one out of 4 clothing combinations (NBC protective garment \[charcoal base\], combat garment and 2 different types of work uniforms). Physiological stress will be evaluated from rectal temperature and heart rate measurements.

Eligibility criteria: Inclusion Criteria:

* Aged 18-30 years.
* Healthy civilian volunteers.
* Without known medical illness or medication use.

Exclusion Criteria:

* The existence or suspicion of existing cardiac or respiratory disease.
* Hypertension.
* Diabetes.
* Psychiatric condition.
* Any muscles or skeledon condition.
* Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
* Infectious disease 3 days prior to the experiment.

Primary outcomes:
measure: physiological strain (composite)
timeFrame: 10 days for each participant
Secondary outcomes:
measure: Rectal temperature
timeFrame: 10 days for each participant
measure: Skin temperature
timeFrame: 10 days for each participant
measure: Heart rate
timeFrame: 10 days for each participant
measure: Sweat rate (composite)
timeFrame: 10 days for each participant
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba medical center
state: Ramat- Gan
Study officials:
affiliation: Sheba Medical Center
name: Ofir Frenkel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04389047: Comparison of Two Mechanical Ventilation Modes on Oxygenisation
Official title: Comparison of Two Mechanical Ventilation Strategies on Tissue Oxygenization of Patients Undergoing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Mechanical Ventilation
Hypoxia
Tissue Damage
Keywords: bariatric surgery, tissue oxygenization, ventilation
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population involves the elective bariatric surgery patients who have body mass index between 35 and 50 kg/m2.

Brief summary: Comparison the effect of two different mechanical ventilation modes on tissue oxygenization.

Detailed description: Aim of the study is to evaluate and compare the effects of two different mechanical ventilation modes as Volume Controlled Mechanical Ventilation (VCV) and Pressure Controlled Mechanical Ventilation (PCV) on non invasive tissue oxygenization levels of patients who scheduled for bariatric surgery.

Eligibility criteria: Inclusion Criteria:

Patients with Body Mass Index 35 - 50 kg/m2 Patients classified as American Society of Anesthesiologist (ASA) 1-2-3 classification Patients elected for Bariatric surgery

Exclusion Criteria:

Patients who wants to reject of study participation Patients who has any surgical complication during the surgery period Patients with decompensated cardiac failure Patients with Moderate or Severe obstructive/restrictive lung disease Patients with Reynaud disease Patients with Buerger phenomena Patients whıo has Intraoperative airway pressure more than 45 cmH2O Patients who had previous thoracic surgery Patients with Negative Modified Allen test

Primary outcomes:
measure: Oxygenization
timeFrame: peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
measure: Oxygenization-2
timeFrame: post operative 1. hour - 4. hour - 8. hour - 12. hour - 24.hour
measure: Arterial blood gas analysis
timeFrame: Peroperative 0. minute - 30. minute - 60. minute
measure: Arterial blood gas analysis-2
timeFrame: post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
measure: Peripheral oxygen saturation
timeFrame: peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
measure: Peripheral oxygen saturation-2
timeFrame: post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
Secondary outcomes:
measure: Peroperative hemodynamic measurements
timeFrame: peroperative 0. minute - 15. minute - 30. minute - 45. minute - 60. minute
measure: Postoperative hemodynamic measurements
timeFrame: post operative 1.hour - 4. hour - 8. hour - 12. hour - 24.hour
measure: Carbondioxide
timeFrame: peroperative 15. minute - 30. minute - 45. minute - 60. minute
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04876547: Are Cesarean Section and Appendectomy in Pregnancy and Puerperium Interrelated?
Official title: Are Cesarean Section and Appendectomy in Pregnancy and Puerperium Interrelated?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendicitis Acute
Cesarean Wound Disruption With Postnatal Complication
Lead sponsor: Amasya University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who attended prenatal follow-up and delivered from October 1, 2015, to October 1, 2020.

Brief summary: It is not known whether appendectomy for acute appendicitis (AA) increases the Cesarean section (CS) rate and whether CS increases the likelihood of AA and appendectomy in the early puerperium. In this study, delivery type and delivery outcomes and appendectomy during pregnancy and puerperium were analyzed.

Detailed description: This cross-sectional retrospective study was performed on 11513 women, delivered during 2015-2020. Inclusion criteria were patients submitted to appendectomy for AA during pregnancy and the first six weeks after delivery. Evaluating parameters were age, parity, gestational week at birth, delivery type, and babies' birth weight.

Eligibility criteria: Inclusion Criteria: Women aged 18-45 years submitted to appendectomy for acute appendicitis during pregnancy or within the first six weeks after delivery were included.

-

Exclusion Criteria: Cases with missing data were excluded.

-

Primary outcomes:
measure: delivery type
timeFrame: 5 years
Secondary outcomes:
measure: Newborn weight
timeFrame: 5 years
Other outcomes:
measure: Cesarean indications
timeFrame: 5 years
Locations:
city: Amasya
country: Turkey
facility: Banuhan Şahin
Study officials:
affiliation: Gynecology and Obstetrics
name: Banuhan Şahin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00691847: Reducing Edema Following Refractive Surgery
Official title: Reducing Edema Following Refractive Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edema
Keywords: Refractive surgery
Lead sponsor: FORSIGHT Vision3
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: At least 10 subjects following laser refractive procedure

Brief summary: Determine if edema plays a role in refractive surgery

Detailed description: Prospective, comparative study

Eligibility criteria: Inclusion Criteria:

1. Patients who underwent bilateral Refractive surgery for myopic correction.
2. Age 18-60.
3. Evidence of an epithelial defect.
4. Uncorrected visual acuity at study visit better than 20/40
5. Patients able to understand the requirements of the study and willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits.

Exclusion Criteria:

1. Any other anterior segment abnormality other than that associated with Refractive surgery.
2. Any abnormalities associated with the eye lids.
3. Prior laser treatment of the retina.
4. Any ophthalmic surgery performed within three (3) months prior to study excluding Refractive surgery.
5. Diagnosis of glaucoma.
6. Active diabetic retinopathy.
7. Clinically significant inflammation or infection within six (6) months prior to study.
8. Uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the Investigator.
9. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device.
10. Intolerance or hypersensitivity to topical anesthetics
11. A medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
12. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient.

Primary outcomes:
measure: Corneal Thickness
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sorasky Medical Center
Study officials:
affiliation: Sorasky Medical Center
name: David Verssano, MD
role: PRINCIPAL_INVESTIGATOR
References: