louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03906383: Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes
Official title: Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Ischemia
Diabetes Complications
Ischemia
Diabetes Mellitus, Type 1
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown whether this can be used in retinal ischemic diseases. The purpose of the present study is to examine if the autoregulation of retinal vessel diameters in diabetic patients change after remote ischemic conditioning and if the observations are different from what have been observed in normal persons.


Eligibility criteria: Inclusion Criteria:

* Diabetes type 1
* Diabetic retinopathy

Exclusion Criteria:

* Previous treatment for diabetic retinopathy
* Other ocular and systemic diseases requiring treatment
* Pregnancy or lactation

Primary outcomes:
measure: Diameter change of retinal vessels
timeFrame: Immediately after and one hour after
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: University of Aarhus
state: Danmark
Study officials:
References:
citation: El Dabagh Y, Petersen L, Pedersen M, Bek T. Reduced baseline diameter and contraction of peripheral retinal arterioles immediately after remote ischemia in diabetic patients. Graefes Arch Clin Exp Ophthalmol. 2019 Oct;257(10):2095-2101. doi: 10.1007/s00417-019-04407-x. Epub 2019 Jul 4.
Clinical trial NCT00294983: OCD Among Patients With Burns
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obsessive-Compulsive Disorder
Burns
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-02-22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: Estimating the prevalence of OCD symptoms among patients with burns


Eligibility criteria: Inclusion Criteria:

* Patients with burns for at least 6 months and are under treatment

Exclusion Criteria:

* Was not defined

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Joseph Zohar, MD
role: STUDY_DIRECTOR
affiliation: Tel Aviv University
name: Nitsa Nacasch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05936983: Comparison of Physical Fitness, Physical Activity Level in Patients With Bipolar Disorder and Schizophrenia
Official title: Comparison of Physical Fitness, Physical Activity Level, Depression and Quality of Life in Patients With Bipolar Disorder and Schizophrenia With Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Schizophrenia
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Bipolar disorder and schizophrenia come to the community mental health center regularly

Brief summary: According to the World Health Organization; Bipolar disorder ranks in the top 20 causes of disability among all medical conditions and 6th among mental disorders worldwide. Bipolar disorder is noted as a serious mental illness involving emotional ups and downs.

Detailed description: Schizophrenia is a chronic mental disorder characterized by the appearance of both positive symptoms such as hallucinations and delusions and negative symptoms such as apathy and withdrawal, repetition of cognitive skills, and disorganization. In this study, it was aimed to compare physical fitness, physical activity level, depression and quality of life in bipolar disoder and schizophrenic patients with healthy individuals.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with bipolar disorder and schizophrenia by a physician according to DSM-5 criteria

  * Individuals with bipolar and schizophrenia between the ages of 30-55
  * Patients without any other accompanying psychiatric disorder
  * Patients who can communicate
  * Patients who agreed to participate in this study and gave informed consent

Exclusion Criteria:

* Patients with a psychiatric diagnosis other than bipolar and schizophrenia.
* Pregnancy condition
* Those who did not consent to participate in the study

Primary outcomes:
measure: Waist measurement - Antropometric Measurements
timeFrame: 4 weeks
measure: Abdomen measurement - Antropometric Measurements
timeFrame: 4 weeks
measure: The hip measurement - Antropometric Measurements
timeFrame: 4 weeks
measure: Eurofit Test Battery
timeFrame: 4 weeks
measure: Quick Inventory of Depressive Symptomatology (QIDS-SR16) scale
timeFrame: 4 weeks
measure: International Physical Activity Questionnaire
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
affiliation: Yeditepe University
name: Ebru Akbuğa Koç
role: PRINCIPAL_INVESTIGATOR
affiliation: Kartal Dr. Lütfi Kirdar City Hospital
name: İsmail Koç
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000583: Hepatitis B Vaccine Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 1999-10-28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: PREVENTION

Brief summary: To determine the efficacy of a hepatitis vaccine in preventing hepatitis B.

Detailed description: BACKGROUND:

Although most carriers of HBsAg are asymptomatic, a substantial proportion eventually develop chronic active hepatitis and cirrhosis. There is also overwhelming evidence that the hepatitis B virus is the single most important causative factor of hepatocellular carcinoma. Thus, mass immunization programs against HBV infection may ultimately affect not only the incidence of acute hepatitis B and the pool of chronic carriers but may also reduce the morbidity and mortality from chronic active hepatitis, cirrhosis, and hepatocellular carcinoma.

Krugman and his co-workers laid the groundwork for active immunization against hepatitis B in 1970 to 1973. They discovered that a 1:10 dilution of hepatitis B infective serum lost its infectivity when boiled for one minute but retained its antigenicity and prevented hepatitis B in 70 percent of vaccinated subjects. Hilleman and his colleagues at the Merck Institute of Therapeutic Research developed a more sophisticated vaccine consisting of highly purified, formalin-inactivated HBsAg particles derived from the plasma of chronic carriers of the antigen. By 1978, data were sufficient to permit testing in a clinical trial.

The first subject was inoculated in November 1978, and by October 1979, recruitment had ended. In May 1980, all trial events were reviewed and classified by an expert panel. In June 1980 the code of vaccine and placebo allocation was broken.

DESIGN NARRATIVE:

Randomized, double blind, fixed-sample. A total of 549 subjects were allocated to the vaccine group in which they were treated with highly purified formalin-inactivated virus subunits derived from the plasma of chronic carriers of hepatitis B. A total of 534 were allocated to the placebo group. Both groups received injections at 0, 1 month, and 6 months unless evidence of infection developed before the series was completed.

Eligibility criteria: Men at high risk for hepatitis B virus infection, 36 years of age or younger, no recent symptoms of hepatitis, blood specimen negative for HBsAg, anti-HBs and anti-HBe.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Szmuness W, Stevens CE, Harley EJ, Zang EA, Oleszko WR, William DC, Sadovsky R, Morrison JM, Kellner A. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. N Engl J Med. 1980 Oct 9;303(15):833-41. doi: 10.1056/NEJM198010093031501.
Clinical trial NCT01229683: Effects of Interscalene Brachial Plexus Nerve Blocks on the Hand and Forearm
Official title: Effects of Interscalene Brachial Plexus Nerve Blocks on the Hand and Forearm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Surgery
Interscalene Nerve Block
Keywords: UCSD
Perineural Nerve Block
Shoulder Surgery
Pain
Grip Strength
Sensation
Interscalene Nerve Block
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will consist only of patients undergoing orthopedic shoulder surgery.

Brief summary: Research study to determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia.

Detailed description: This is a research study to prospectively determine the proportion of cases in which an interscalene brachial plexus nerve block produces hand and forearm anesthesia. The investigators will investigate this issue in patients having shoulder and not hand/forearm surgery. We will test hand grip strength and sensation to determine if the hand and forearm are responding to the anesthesia.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* unilateral orthopedic shoulder surgery
* already desiring an interscalene brachial plexus nerve block for postoperative analgesia with the anesthetic plan including a preoperative interscalene nerve block with mepivacaine

Exclusion Criteria:

* any known contraindication to study medications or testing hand grip strength pre/post-op
* insulin-dependent diabetes mellitus
* neuropathy of any etiology in the affected extremity
* any anticipated incision site apart from the shoulder
* Obesity
* Pregnancy
* Incarceration
* inability to communicate with the investigators and hospital staff

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Centers (Hillcrest and Thornton)
state: California
Study officials:
affiliation: University of California, San Diego
name: Brian M Ilfeld, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01403883: Psychological and Enterostomal Therapy Care
Official title: Impact of Psychological and Enterostomal Therapy Care for Patient Undergoing Rectal Cancer Resection With a Temporary Stoma. Monocentric Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Rectum
Keywords: Rectal cancer
Temporary stoma
Psychological disorders
Lead sponsor: Association de Recherche Experimentale et Clinique en Chirurgie Digestive
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In case of rectal cancer surgery, temporary stoma is recommended to decrease the risk of postoperative anastomotic leakage. The aim of the study was to assess the benefit of an optimal care, i.e., both psychological and enterostomal therapy care.

Detailed description: The aim of the study is to asses the benefit of an optimal and specific care concerning the temporary stoma in patients operated for rectal cancer surgery in term of psychological and enterostomal therapy effect.

This study is a monocentric and randomized trial.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 y
* Rectal adenocarcinoma (tumor height \< 15 cm from the anal verge) with or without pre operative radiochemotherapy.
* Open or laparoscopic rectal excision with partial or total meso rectal excision with sphincter preservation by colo rectal or colo anal anastomosis.
* Temporary stoma.
* Patient consent
* Patient with national health affiliation

Exclusion Criteria:

* Stage IV disease with synchronous hepatic or pulmonary metastases
* Colonic cancer \> 16 cm
* Associated surgical procedure (Hepatic resection, small bowel resection subtotal colectomy)
* Abdominal perineal resection
* Associated comorbidity
* Emergency surgery
* Psychological care refusal

Primary outcomes:
measure: Evolution of Global Quality of life (SF36)
timeFrame: at Day45, Day0, Day45, Day60, Day90
measure: Evolution of Psychological anxiety score (STAI/Beck)
timeFrame: at Day-45, Day0, Day45, Day60, Day90
Secondary outcomes:
measure: Evolution of Specific stoma score and stoma care learning
timeFrame: at Day-45, Day0, Day45, Day60, Day90
measure: Hospital stay
timeFrame: at Day90
measure: Overall morbidity
timeFrame: at Day45, Day60, Day90
measure: Specific stoma related morbidity
timeFrame: at Day45, Day60, Day90
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Yves PANIS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00756483: Stability Plus - Outcomes From Extended Continuum of Care
Official title: Study the Effects of Pre- and Post-Operative Resistive Exercise in Total Arthroplasty Patients Using the Stability Plus Exercise System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthroplasty
Keywords: Resistance
Exercise
Lead sponsor: Stability Plus, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Missouri-Columbia
First posted: 2008-09-22
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that have undergone total joint replacement - hip or knee

Brief summary: Basic Protocol

1. Identify participant(s)
2. Request patient participation/Acquire Consent
3. Register patient at www.stabilityplus.net through the LOGIN tab

   * Patient ID (Name/Initials/SSN or any combination thereof)
   * Gender
   * Age
   * Surgical Procedure
   * Date of Surgery
   * Select Basic Exercise Program that corresponds with Surgical Procedure
4. Perform Initial Assessment using Basic Exercises for the Surgical Procedure
5. Enter Assessment Data at www.stabilityplus.net (through the LOGIN tab/Portal)
6. Within portal, modify Basic Exercise Program to create customized Stability Plus prescription for the patient
7. Monitor patient progress through Stability Plus portal.


Eligibility criteria: Inclusion Criteria:

* Undergone total joint replacement
* Must be able to complete pre-operative strength assessment
* Must be able to exercise using specified resistive bands

Exclusion Criteria:

* Non-ambulatory patients

Primary outcomes:
measure: Pre- and post- study strength assessment tests for joint specific exercises
timeFrame: 3 months, 6 months and 12 months
Secondary outcomes:
measure: Reduced recovery time versus current norm
timeFrame: 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Hospital
state: Missouri
Study officials:
affiliation: Stability Plus, LLC
name: James T Yost
role: STUDY_DIRECTOR
References:
Clinical trial NCT05834283: Aerobic vs Core Stability Exercise Training Program in Women With Endometriosis
Official title: Comparative Effects of Aerobic and Core Stability Exercise Training Program on Pain, Sleep and Quality of Life in Women With Endometriosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Keywords: endometriosis
Aerobic exercises,
core stability,
Quality of life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of aerobic and core stability exercise training program on pain, sleep and quality of life in women with endometriosis.


Eligibility criteria: Inclusion Criteria:

* Age 24-45

  * Diagnosed patients with endometriosis
  * Pain lasting more than 6 months
  * Chronic pelvic pain
  * Infertility
  * Patients with dysmenorrhea.

Exclusion Criteria:

* Patients with the tubo- ovarian abscess.

  * Concomitment use of hormonal drugs.
  * Any malignancy
  * Impaired sensation..
  * Patients with Gynecological hemorrhage

Primary outcomes:
measure: Numeric pain rating scale for pain
timeFrame: 8 weeks
measure: Endometriosis health profile questionnaire (EHP 30) for quality of life.
timeFrame: 8 weeks
measure: Pittsburgh sleep quality index (PSQI) for sleep.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Family Health Hospital
state: Punjab
Study officials:
affiliation: Riphah International University, Senior lecturer
name: Hafiza Neelam, PPDPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vigano P, Parazzini F, Somigliana E, Vercellini P. Endometriosis: epidemiology and aetiological factors. Best Pract Res Clin Obstet Gynaecol. 2004 Apr;18(2):177-200. doi: 10.1016/j.bpobgyn.2004.01.007.
citation: Bourdel N, Alves J, Pickering G, Ramilo I, Roman H, Canis M. Systematic review of endometriosis pain assessment: how to choose a scale? Hum Reprod Update. 2015 Jan-Feb;21(1):136-52. doi: 10.1093/humupd/dmu046. Epub 2014 Sep 1.
citation: Ferrero S, Alessandri F, Racca A, Leone Roberti Maggiore U. Treatment of pain associated with deep endometriosis: alternatives and evidence. Fertil Steril. 2015 Oct;104(4):771-792. doi: 10.1016/j.fertnstert.2015.08.031. Epub 2015 Sep 10.
citation: Chauvet P, Auclair C, Mourgues C, Canis M, Gerbaud L, Bourdel N. Psychometric properties of the French version of the Endometriosis Health Profile-30, a health-related quality of life instrument. J Gynecol Obstet Hum Reprod. 2017 Mar;46(3):235-242. doi: 10.1016/j.jogoh.2017.02.004. Epub 2017 Feb 7.
citation: Cheong Y, William Stones R. Chronic pelvic pain: aetiology and therapy. Best Pract Res Clin Obstet Gynaecol. 2006 Oct;20(5):695-711. doi: 10.1016/j.bpobgyn.2006.04.004. Epub 2006 Jun 9.
Clinical trial NCT02577783: PDD vs PAD to Treat Initially Diagnosed MM
Official title: Doxorubicin Hydrochloride Liposome vs Doxorubicin Combined With Bortizomib and Dexamethasone to Treat Initially Diagnosed Multiple Myeloma: A Randomized Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Multiple Myeloma
Keywords: Doxorubicin Hydrochloride
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether doxorubicin hydrochloride liposome is superior to doxorubicin when combined with bortizomib and dexamethasone for treating patient with initially diagnosed multiple myeloma.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed and untreated multiple myeloma patients
* Patients with age between 18 and 70 years
* With a evaluable disease
* ECOG score ≤2
* NE≥1.0×10E9 /L, Plt≥50×10E9 /L, Hb≥70 g/L
* AST, ALT, ALP≤3×ULN, serum BIL≤ULN
* LVEF≥ 50%
* Not in pregnancy
* Written informed consent are acquired

Exclusion Criteria:

* Severe heart failure (NYHA grade II or higher)
* Active and uncontrolled severe infection
* HIV positive
* Have accepted any other anti-tumor drug within 30 days before the first dose of doxorubicin hydrochloride iposome or doxorubicin
* Grade 2 or higher peripheral neuropathy before treatment
* Have suffered any other malignancy in past 5 years
* Females in lactation
* Other situations that investigators consider as contra-indication for this study

Primary outcomes:
measure: Response rate
timeFrame: 4 cycles (each cycle is 28 days) of chemotherapy
Secondary outcomes:
measure: Overall remission rate
timeFrame: 4 cycles (each cycle is 28 days) of chemotherapy
measure: Progression-free survival
timeFrame: 3 year
measure: Adverse Event
timeFrame: 3 year
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: