louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05505695: The Effect of Schroth Exercises on Pulmonary Function in Adolescent Idiopathic Scoliosis
Official title: The Effect of Schroth Exercises on Pulmonary Function in Adolescent Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Pulmonary Function
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Halic University
First posted: 2022-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: In the present study, we aimed to evaluate the effect of regular Schroth exercises on pulmonary functions in adolescent idiopathic scoliosis (AIS) patients who use rigid braces and perform Schroth exercises regularly.

Objective: The main purpose of this study, is to investigate the effects of Schroth exercises on pulmonary functions in adolescents who use rigid braces and perform Schroth exercises regularly.

Methods: Twenty-four patients with AIS were included in the study. The patients who wore rigid braces and performed the SSE therapy constituted the "Brace\&Exercise" (N=12), and the patients who wore full-time rigid braces but did not perform exercise constituted the "Brace Group" (N=12) of the study. The effects of Schroth exercises on pulmonary functions were measured at the beginning of treatment and the 8th week of the treatment.

Keywords: Adolescent, idiopathic scoliosis, conservative treatment, brace, respiratory function, Schroth exercises.


Eligibility criteria: Inclusion Criteria:

* 10-16 years,
* 25-45 Cobb degree,
* Brace and exercise treatment prescribed by the physician
* Participation in the study was approved by the family/caregiver

Exclusion Criteria:

* Chronic respiratory diseases,
* Professional athletes,
* Did not perform the exercises regularly
* Did not compliance the brace

Primary outcomes:
measure: FVC - Respiratory Functions
timeFrame: 8 Weeks
measure: FEV1 - Respiratory Functions
timeFrame: 8 Weeks
measure: PEF - Respiratory Functions
timeFrame: 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Halic University
Study officials:
References:
Clinical trial NCT02097095: Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)
Official title: Substudy of GSK Protocol TB-018: Collection and Storage of Biological Samples for Evaluation of Correlates of Tuberculosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Keywords: Correlates of risk
TB
Tuberculosis
Sub-study
TB-018
Lead sponsor: Aeras
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2014-03-26
Enrollment: 3253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who have consented to participate in TB-018 will be approached for participation in this sub-study. Subjects who have consented to participate in TB-018 are not required to participate in this sub-study.

Brief summary: This is an independent optional sub-study parallel to TB-018 (NCT01755598) in which biological samples will be collected for future investigations on biological correlates, markers or prognostic factors for TB disease. Subjects who consent to enroll in TB-018, "A phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate tuberculosis (TB) vaccine GSK 692342 (M72/AS01E) against TB disease, in healthy adults aged 18-50 years, living in a TB endemic region", (see NCT 01755598) will be asked to participate in this sub-study. Subjects enrolled in TB-018 who also consent to C-041-972 will be followed according to the TB-018 protocol but will have additional blood samples collected for the sub-study.

Detailed description: Additional information in the protocol

Eligibility criteria: Inclusion Criteria:

To be eligible for this sub-study, subjects must be enrolled in TB-018 and provide separate written informed consent for C-041-972. See NCT 01755598 for inclusion criteria into TB-018.

Exclusion criteria:

To be eligible for this sub-study, subjects must be enrolled in TB-018 and provide separate written informed consent for C-041-972. See NCT 01755598 for exclusion criteria into TB-018.

Primary outcomes:
measure: Collect and store biological samples for future use to evaluate potential biological markers correlated to the risk for tuberculosis.
timeFrame: 36 months in parallel with main study TB-018 (NCT01755598).
Secondary outcomes:
measure: Collect and store biological samples for future use to evaluate immune correlates of protection from tuberculosis in subjects vaccinated with GSK 692342 (M72/AS01E).
timeFrame: 36 months in parallel with main study TB-018 (NCT01755598).
Other outcomes:
Locations:
Study officials:
affiliation: Aeras
name: Bernard Landry, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06186895: Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Laparoscopic Sleeve Gastrectomy
Official title: Dexmedetomidine Versus Fentanyl on Postoperative Analgesic Profile in Patients With Morbid Obesity Undergoing Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Dexmedetomidine, fentanyl, analgesia,Sleeve Gastrectomy
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine (Dex) activates the α2 adrenergic receptor that is present within the locus coeruleus, leading to anxiolysis, hypnosis, analgesia, and sedation.

We conducted our research to compare the effects of fentanyl and DEX on the postoperative analgesic profile and complications in morbidly obese patients after sleeve gastrectomy.

Detailed description: The participants were assigned to two groups of equal size (32 patients in each group) by the use of computer-generated numbers and sealed opaque envelopes. The participants allocated to the DEX group, also known as Group D, received an intravenous loading dose of DEX (1 μg/kg) over 15 minutes prior to the anesthetic induction. Following the intubation procedure, a maintenance infusion of DEX was delivered at a rate of 0.6 μg/kg/h. The infusion was discontinued upon trocars removal. The patients assigned to the fentanyl group (referred to as Group F) were administered fentanyl (1 μg/kg) that was given intravenously slowly over 60 seconds before induction of anesthesia as a loading dose. Following intubation, a continuous infusion of fentanyl was administered at a rate of 1μg/kg/hr. The infusion was discontinued upon the removal of the trocars.

Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) of 35 kg/m2 or more.
* American Society of Anesthesiology (ASA) physical status of II-III.
* all participants would have a laparoscopic sleeve gastrectomy (LSG).

Exclusion Criteria:

* allergy to α2 -adrenergic agonist.
* kidney, liver, neuromuscular disorders, and cardiac disease.
* or patients on opioid medications.

Primary outcomes:
measure: visual analogue score
timeFrame: from arrival to PACU until 12 hours after surgery
Secondary outcomes:
measure: The time of the first analgesic request
timeFrame: first postoperative day
measure: the total opioid dose consumed during the first 12 hours postoperatively
timeFrame: 12 hours after surgery
measure: incidence of nausea and vomiting
timeFrame: 2 hours after surgery
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ryad Ghoraba
state: Gharbia
Study officials:
References:
Clinical trial NCT01125995: Early Versus Late Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
Official title: A Randomized Phase III Trial for Timing of Radiation in Concurrent Chemoradiation for Limited Stage Small-cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Small Cell Lung Cancer
Keywords: limited disease
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 222
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: The purpose of the study is to evaluate the efficacy and toxicity of different timing of concurrent chemoradiation in the treatment of limited disease status Small-cell lung cancer.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed small-cell lung cancer
* limited disease status
* with evaluable disease
* 18 years or older
* ECOG performance status 0,1,2
* expected survival time should be 12 weeks or longer
* Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 50mL/min
* Written informed consent form

Exclusion Criteria:

1. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
2. Patients with active infection requiring antibiotics
3. Pregnant or nursing women ( Women of reproductive potential have to agree to use an effective contraceptive method)
4. Prior history of malignancy within 5 years from study entry except for a adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, well-treated thyroid cancer
5. previous history of chemotherapy or radiotherapy

Primary outcomes:
measure: complete response rate
timeFrame: 6 months
Secondary outcomes:
measure: overall survival
timeFrame: 36 months
measure: objective response rate
timeFrame: 6 months
measure: Progression-free survival
timeFrame: 36 months
measure: toxicity by NCI common toxicity version 2.0
timeFrame: 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Keunchil Park
city: Seoul
country: Korea, Republic of
facility: Asan Medican Center
Study officials:
affiliation: Samsung Medical Center
name: Keunchil Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00457795: 24-hour IOP-lowering Effect of Brimonidine 0.1%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-04-09
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* allergy to brimonidine
* inability to complete 24 hour stay for monitoring

Primary outcomes:
measure: Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
timeFrame: Baseline, Week 4
measure: Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4
timeFrame: Week 4
measure: Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4
timeFrame: Week 4
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT05560295: Hysteroscopic Surgery; Retrospective Cross-sectional Study of Reproductive Outcome
Official title: Fertility-enhancing Hysteroscopic Surgery; Multi-center Retrospective Cross-sectional Study of Reproductive Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysteroscopic Metroplasty and Myomectomy
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 165
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female population with infertility or recurrent miscarriages who have uterine septum or fibroids

Brief summary: study of the effect of hysteroscopic sptoplast and hysteroscopic myomectomy on reproductive performance of patients with infertility and /or miscarriages

Detailed description: Retrospective study and analysis of the reproductive outcome in patients who underwent hysteroscopic surgery for infertility at Jordan university hospital and Al-Noor fertility centre in Amman, Jordan in the period September 2016-october 2021. Patients were followed up for a minimum of 6 months after surgery. Resection of uterine septum or submucosal fibroids were included. Data was obtained from the electronic and paper-based clinical files for patients who were operated upon at these hospitals. Patients who missed follow up after the operation will be contacted by phone or invite them for a clinic review to know of their fertility status and pregnancy outcome.

Eligibility criteria: Inclusion Criteria:

* those with primary or secondary infertility of more than 1 year with normal seminal fluid analysis, normal female hormonal profile, patent fallopian tubes bilaterally (as confirmed by hysterosalpingography HSG), normal thyroid function, no previous uterine surgery and no medical diseases.
* Cases with recurrent miscarriages were those with 2 or more first or second trimester miscarriages of an apparently normal singleton fetus with no hormonal, endocrine or maternal or paternal karyotype abnormalities and with no previous history of term pregnancy(s).

Exclusion Criteria:

* All patients who were operated upon outside the context of infertility (heavy bleeding...etc), patients with combined (maternal and paternal) infertility factors,
* Patients with history of any number of term pregnancy,
* Previous uterine surgery,
* Patients with medical diseases,
* Those with abnormal female hormonal profile,
* Those with other potential factors for infertility including endometriosis
* Patients with incomplete or missing data and could not be contacted.
* Patients who had myomectomy or septal resection done using bipolar hysteroscopy

Primary outcomes:
measure: pregnancy rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01623895: Pharmacogenetic Study in Patients Received Iron Chelating Agent
Official title: Pharmacogenetic Study in Patients Received Iron Chelating Agent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemosiderosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 100
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received deferasirox because of transfusion associated iron overload

Brief summary: To investigate effect of genetic variations on the toxicities and find optimal target population, the investigators planned to analyze the genetic polymorphisms of UDP-glucuronosyltransferase.

Detailed description: Transfusion-associated iron overload induces systemic toxicity. Recently, deferasirox, a convenient long acting oral agent, has been introduced in clinical practice with promising efficacy. However, some patients experience drug-related toxicities and cannot tolerate it. To investigate effect of genetic variations on the toxicities and find optimal target population, we planned to analyze the genetic polymorphisms of UDP-glucuronosyltransferase 1A (UGT1A) subfamily, multi-drug resistance-associated protein 2 (MRP2) and breast cancer resistance protein (BCRP) among pediatric patients received deferasirox.

Eligibility criteria: Inclusion Criteria:

1. Patients who received deferasirox because of transfusion associated iron overload (Transfusion associated iron overload was defined as ferritin ≥ 1,000 ng/mL in patients who needed over 8 units of RBC transfusions per a year).
2. Patients with written informed consents

Exclusion Criteria:

Patients or parents refusal

Primary outcomes:
measure: Genetic polymorphism associated with side effects of deferasirox
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Chongno-gu
Study officials:
References:
Clinical trial NCT05326295: Evaluation of Treatment Efficacy by Circulating Tumor Cell Phenotype Surveillance in Breast Cancer Patients
Official title: Surveillance of Circulating Tumor Cell Phenotype in Early Stage Breast Cancer Patients With Neoadjuvant Chemotherapy or Adjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Neoplasms
Neoplastic Cells, Circulating
Chemotherapy Effect
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Early stage breast cancer patients

Brief summary: The phenotype of circulating tumor cells (CTCs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with/without adjuvant chemotherapy. The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the prognosis of breast cancer patients.

Detailed description: The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the treatment response of neoadjuvant chemotherapy, surgery and adjuvant chemotherapy. This study also aims to evaluate the efficacy of CTCs surveillance in predicting invasive-disease free survival (iDFS), overall survival (OS) and metastasis. Additionally, this study evaluate the expression of PDL1 and FOXC3 on CTCs.

Eligibility criteria: Inclusion Criteria

* The age is more than 18 years old;
* Pathology confirmed malignant breast tumor;
* No clinical diagnosis of other malignancies, unstable complications or uncontrolled infection;
* Life expectancy is greater than 6 month;
* The main organ function is normal;
* The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance.

Exclusion Criteria

* Patients who had suffered from other malignant tumors;
* With uncontrolled bacterial, viral or fungal infections;
* With physical or mental disorders
* Without or limited civil capacity;
* Infected with human immunodeficiency virus (HIV)；
* Circumstances in which the investigator considers it inappropriate to participate in this study.

Primary outcomes:
measure: iDFS
timeFrame: From date of enrollment through study completion, up to 10 years.
Secondary outcomes:
measure: overall survival
timeFrame: From date of enrollment through study completion, up to 10 years.
measure: Pathological complete response rate
timeFrame: From date of enrollment up to 24 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT04049695: Improving Cognition After Cancer
Official title: A Randomized Trial of Physical Activity for Cognitive Functioning in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer Survivors
Cognitive Dysfunction
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 253
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.

Detailed description: Many breast cancer survivors experience problems with mental abilities such as memory, attention, and concentration (known as cognition). Increasing physical activity has been shown to improve cognition in adults; however, little is known about whether this is helpful for cancer survivors as well. This study will test whether a physical activity intervention can improve cognition in breast cancer survivors and help the development of physical activity guidelines for cognition in breast cancer survivors.

Eligibility criteria: Inclusion Criteria:

* breast cancer survivors who have completed active treatment at least 6 months prior to enrollment and are within 5 years of diagnosis of stage 1, 2, or 3 breast cancer
* self-report difficulties with cognition since their cancer diagnosis
* self-report low levels of moderate to vigorous physical activity
* have a Fitbit compatible device with internet
* breast cancer was treated with chemotherapy and/or hormonal therapy

Exclusion Criteria:

* medical condition that could make it potentially unsafe to be in an unsupervised physical activity intervention
* currently taking tamoxifen or aromatase inhibitor that will be stopped in the next 6 months
* unable to commit to a 12-month study

Primary outcomes:
measure: National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: National Institutes of Health Toolbox - Cognition Domain - Oral Symbol Digital Test
timeFrame: Baseline to 12 months
measure: Patient Reported Outcomes Measurement Information System (PROMIS) cognitive abilities
timeFrame: Baseline to 6 months and Baseline to 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
Study officials:
References: