cyrilzakka/clinical-trials huggingface dataset:
Development of AECOPD Identification Tool (DETECT Study)

This study is an observational, multi-center and cross sectional study,to develop an identification tool on purpose of differentiating COPD exacerbation from patients with respiratory symptoms in community hospitals of China.

This is an observational, multi-center and cross-sectional study to develop an AECOPD identification tool. Estimated totally 7 tertiary hospitals with experts in respiratory area will be involved as the study sites. These study sites will cover the regions of China (Eastern, Southern, Northern, Central, Western and Northeastern region), to be representative for the patient features all over the country. The patients will be enrolled in a "consecutive" way, which is, the investigators will recruit the patients who are eligible and consented to participate in this study without personal tendency.

For the enrolled patients, a face to face visit between investigator and patient will be arranged. The evaluation for the symptoms and signs will be performed and the relevant data will be collected on the visit. In addition, other relevant tests (e.g. oxygen saturation, blood test, CAT, etc) and data (demographic, medical history, etc) will be collected on this visit.

Eligibility Criteria:
Inclusion Criteria:

-≥ 40 years old of age.

* Able to adequately understand written and verbal
* A signed and dated written informed consent must be obtained prior to the visits
* Patients see doctors due to suffering respiratory disease below:

Disease type 1 - diagnosed moderate and severe stable COPD

* Patients with a diagnosis of COPD and documented record with predicted ratio of FEV1 to forced vital capacity (FVC) \< 0.70 before the study visit
* COPD with moderate to severe airflow obstruction (FEV1\<0.8 predicted)

Disease type 2 - AECOPD

* Patients with a diagnosis of COPD and documented record with predicted ratio of FEV1 to forced vital capacity (FVC) \< 0.70 before the study visit
* Patients consult the clinic or the emergency department because of acute worsening with an AECOPD (diagnosed by more than 2 clinical experts and refer to diagnosis criteria of Appendix 2)

Disease type 3

-Non-COPD patients with chronic respiratory symptoms such as cough, sputum and wheeze, dyspnea etc. (≥2 high risk factors )

Exclusion Criteria:

* Patients with severe cardiovascular disease, including uncontrolled hypertension with drug treatment, unstable angina, myocardial infarction within the last 6 months, NYHA class II congestive heart failure, severe arrhythmia, pericardial effusion, etc.
* Patients with lung cancer, esophageal cancer or mediastinal tumors;
* Patients who participated in any drug clinical trials within 4 weeks before enrollment;
* Patients with severe infection, indicated for intravenous antibiotics, antifungal or antiviral therapy;
* Patients suffering from mental illness and poor compliance;
* Patients inappropriate for inclusion decided by investigator.
Observational Study To Assess The Effectiveness and Treatment Adherence Of Tofacitinib of Ulcerative Colitis In Clinical Practice In Sweden

This is a prospective observational study using data from an existing, ongoing National Swedish registry (SWIBREG). This study is designed to assess the effectiveness and treatment adherence of tofacitinib on clinical disease activity parameters in patients with ulcerative colitis in Swedish clinical practice. The study will also assess treatment adherence of tofacitinib using the Swedish Prescribed Drug Register.


Eligibility Criteria:
Inclusion Criteria:

* The assignment of the patient to tofacitinib is not decided in advance by the protocol but falls within clinical practice and the prescription of the medicine is done according to the SmPC and is clearly separated from the decision to include the patient in the study.
* The patient must sign the informed consent before enrollment in the study. The informed consent permits extraction of data from SWIBREG at baseline and during the duration of the study. For patients not registered in SWIBREG, they must complete all SWIBREG consents and registration at the time of treatment initiation. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* Patients, male or female, must be 18 years old or above.
* The patient must have active disease as confirmed by fecal calprotectin \>250 mg/kg or endoscopic assessment corresponding to a Mayo endoscopic subscore ≥2 not more than 4 weeks prior onset to the initiation of tofacitinib treatment. This inclusion criteria applies also to patients that have already been enrolled in the study.

Exclusion Criteria:

* The patient is enrolled in a clinical trial in which the treatment of ulcerative colitis is dictated by a study protocol. If the patient is participating in another ongoing observational study (non-interventional), the patient may be included in this observational study.
* Patients that fulfill any of the contraindications according to the latest version of the SmPC. Any SmPC label updates will be communicated to all study sites.
* For whatever reason the physician feels the patient unsuitable to participate in the study.
Versartis Trial in Children to Assess Long-Acting Growth Hormone

This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a single subcutaneous injection of VRS-317. During the Phase 2a stage, patients will receive 6 months of VRS-317 treatment at dose levels selected from the Phase 1b stage. The primary endpoints for the study are to determine the safety and efficacy of repeat dose VRS-317.

In Phase 1b, separate cohorts of patients will be tested in a single ascending dose format. Safety review committee meetings will take place prior to escalating to each increasing dose level. Enrolled patients will be monitored for 60 days for safety with PK/PD and safety labs collected.

Two dose levels will be selected after completion of Phase 1b to be tested during Phase 2a (6 months of continuous VRS-317 treatment). Safety and PK assessments will be made during the Phase 2a stage. Patient heights will be measured by stadiometer.

Eligibility Criteria:
Inclusion Criteria:

* Chronological Age ≥ 3.0 years and ≤ 11.0
* Diagnosis of GHD as documented by GH stimulation test
* Below average height SDS at screening
* Appropriate weight for Stature
* Decreased IGF-I SDS at screening
* Delayed bone age
* Normal thyroid function test results at screening visit
* Legally authorized representative informed consent.

Exclusion Criteria:

* Prior treatment with any growth promoting agent
* Documented history of, or current, significant disease
* Chromosomal aneuploidy, significant gene mutations
* Diagnosis of Attention Deficit Hyperactivity Disorder
* Daily use of anti-inflammatory doses of glucocorticoid
* Prior history of leukemia, lymphoma, sarcoma or cancer
* Known allergy to constituents of the study drug formulation
* Abnormal ocular findings at screening
* Significant abnormality in screening laboratory studies
Chronic Effects of the Use of Instep Weights on Specific Capacities in Soccer Players

The main goal of this randomized controlled trial (RCT) is to evaluate the chronic effects of using instep weights on technical, physical (conditional), and perceptual parameters in amateur male soccer players.

The secondary objective will be to propose a training methodology using instep weights to enhance athletic performance.

The following hypotheses are formulated based on the objectives outlined previously.

Hypothesis 1: the use of instep weights will enhance performance in ball striking speed, change of direction ability, and repeated sprint capacity.

Hypothesis 2: the use of instep weights will negatively affect performance in ball striking accuracy and ball control.

Hypothesis 3: the use of instep weights will not produce adverse effects on perceived exertion, groin pain or reduce maximal adductor, quadriceps and hamstring muscle contraction values.

A RCT will be performed and players will be randomly assigned in one of the two groups (experimental or control).

Players will attend their regular training sessions and the protocol will be divided into two phases:

* Phase 1: familiarization On the recruitment day, players will be briefed on the study procedures, followed by the reading and signing of informed consent forms. Familiarization with the study procedures will take place over the two weeks prior to the intervention phase. During this period, participants will practice all testing protocols once a week and will wear 100-gram instep weights in different training sessions.
* Phase 2: intervention During the intervention phase, all players who meet the inclusion and exclusion criteria will be recruited and will be randomly allocated into an intervention group (experimental) or a non-intervention group (control group). Randomization will be conducted by an external researcher using blocked randomization via a web-based tool (Urbinak, 1997). Both groups will undergo distinct interventions over an 8-week period.

The study will be conducted during the competitive season on artificial turf field under consistent environmental conditions. Players will wear soccer boots for all testing procedures. Testing will occur at three time points:

* Pre-intervention: first day of Week 1 to collect baseline data.
* Mid-intervention: first day of Week 5.
* Post-intervention: first day of Week 9.

Eligibility Criteria:
Inclusion Criteria:

* amateur young male soccer player (under federation regulation)
* minimum three years of experience playing soccer
* train 3 days/week and 5 hours/week (minimum)

Exclusion Criteria:

* Injured players
* Goalkeepers
* Players unable to perform at their best
* Players that will miss more than two training sessions
* Players under medication or using performance enhancement supplements
* Players under 16 years old
Solute Removal With High Volume Hemodiafiltration Versus Long High Flux Hemodialysis

This is a prospective cross-over study including 10 stable hemodialysis patients with chronic kidney disease stage 5. The cross-over study lasts 2 weeks with the study dialysis sessions at midweek.

During one session, the patient will be dialyzed during 4 hours with high volume post dilution hemodiafiltration (HDF) with an FX800 hemodialyzer (Fresenius Medical Care) and a blood flow of 300mL/min, dialysate flow of 500mL/min, and substitution flow of 75mL/min.

During the other midweek session, the patient will be dialyzed during 8 hours with high flux hemodialysis (HD) with an FX80 hemodialyzer (Fresenius Medical Care) and a blood flow of 200mL/min and a dialysate flow of 500mL/min.

The HDF and HD sessions will be randomized. Blood samples will be drawn pre and post dialysis from the arterial blood line, and after 30min after dialysis start, a blood sample will be drawn from the inlet and outlet line.

At the dialysate outlet line, partial dialysate collection is performed at the outlet line.

Blood and dialysate samples will be analyzed for a broad range of retention solutes like small and water soluble solutes, middle molecules, and protein bound solutes.

These data will be further used to calculate solute removal and evaluate any differences between the solute removal during high volume post dilution HDF and high flux HD.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease (CKD) stage 5 with hemodialysis or hemodiafiltration treatment for more than three months.
* No vascular access related problems (Arteriovenous (A/V) fistula, graft or bi-flow catheter)
* Double needle/lumen vascular access
* No ongoing infection
* Singed informed consent form

Exclusion Criteria:

* Inclusion criteria not met
* Known HIV or active hepatitis B or C infection (Positive Polymerisation Chain Reaction (PCR))
* Pregnancy
* Unstable clinical condition (e.g. cardiac or vascular instability)
* Known coagulation problems
* Patients participating in another study interfering with the planned study.
Effects of Progressive Resistance Training Vasomotor Symptoms in Post Menopausal Women

The study will be a randomized clinical trial and will be conducted in Civil Hospital and Kalsoom Hospital Samundry. This study will be completed in time duration of 10 months after the approval of synopsis. Non probability convenience sampling with Randomization technique will be used and 26 participants will be recruited in study after randomization. The subjects will be divided into two groups and the group A will receive Progressive training and Health education and group B will receive only Health education. The data will be assessed at the baseline and after 8th week of treatment. After data collection data will be analyzed by using SPSS version 21.

The significance of this study is that it may improve the postmenopausal symptoms like depression and vasomotor symptoms which includes hot flushes , night sweats etc .in postmenopausal females. The majority of studies examining the vasomotor symptoms affected by symptoms of post menopause have concentrated on the effects of therapies like hormone therapy.To our knowledge, no studies have looked at the connection between vasomotor symptoms,depression and resistance training. Without doing so, it is challenging to understand how Vasomotor symptoms have an impact. This study sought to fill in the knowledge vaccum by examining the resistance training effect on depression , fatigue and vasomotor symptoms.

Eligibility Criteria:
Inclusion Criteria:

Post-menopausal women with age 50 - 60 years Blood pressure less than 160 / 100 More than or equal to 4 moderate-severe vasomotor symptoms including hot flushes, nocturnal sweats, sweating and poor sleep.

Exclusion Criteria:

Chronic metabolic and endocrine diseases Receiving hormone replacement treatment Surgical menopause Cognitive impairment
Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.

The good standard antibiotic prophylaxis pre elective C S is cefazolin and this study will approve addition of azithromycin to cefazolin will reduce post CS infections more than cefazolin only.

Patiants and methods

Randomization:

Patients fulfilling the inclusion criteria will be randomized to two groups. Both two group will receive standard prophylaxis antibiotic CEFAZOLIN (zinol) (at a dose of 1 g) 2 hours preoperative.

Control Group:

This group will include 200women undergoing elective cs. In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.

Study Group:

This group will include 200women undergoing elective cs. In this group, patients will receive only standard prophylaxis antibiotic(CEFAZOLIN)

Inclusion criteria:

* Gestational age of 37 0/7 weeks and greater
* Elective cesarean section
* Medicaly free pregnant women

Exclusion criteria:

* a known allergy to azithromycin
* obstetric complications
* azithromycin use within 7 days before randomization
* chorioamnionitis or other infection requiring postpartum antibiotic therapy
* Pre-gestational diabetes

Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 37 0/7 weeks and greater
* Elective cesarean section
* Medicaly free pregnant women

Exclusion Criteria:

* a known allergy to azithromycin
* obstetric complications
* azithromycin use within 7 days before randomization
* chorioamnionitis or other infection requiring postpartum antibiotic therapy
* Pre-gestational diabetes
Parent-delivered Massage for Children With Autism - Ages 6 to 11

Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute at Western Oregon University (WOU) will be conducting research on the effect of a parent-delivered massage program on measures of autism and general development in children ages 6 to 11 with autism. Families will participate in an initial training, and receive 24 sessions of ongoing support and training from a trained therapist over the first nine months.

Children will be randomly divided into treatment groups and wait-list control groups. The control groups begin treatment five months after the treatment groups begin.

All children will be tested on three occasions in the first year: prior to beginning treatment, and five and twelve months later. Results will be shared with parents at the end of each year. Testers will remain blinded as to which group is currently receiving treatment.

There is no cost to parents for participation in this research study. Families meeting the eligibility criteria will be accepted into the study on a first-come, first-served basis.

Eligibility Criteria:
Inclusion Criteria:

* Have a medical and/or educational diagnosis of autism
* Be between the age of 6 and 11
* Parents willing to attend the parent training session and transport the child to treatment sessions with trained staff 20 times in the first five months
* Parents willing to give the fifteen-minute massage daily
* Parents willing not to start any new interventions unless medically necessary

Exclusion Criteria:

* Taking psychoactive medication or pharmaceutical chelation therapy
* Additional chronic disability (for example, cerebral palsy or uncontrolled seizures)
* Receiving more than fifteen hours per week of intensive behavioral treatment for autism (e.g. Applied Behavior Analysis therapy)
Brassica Intake and Isothiocyanate Absorption

Healthy individuals (n=18) will participate in 2 controlled-feeding study periods that are 3 weeks each in length: 1) Control diet 2) Brassica diet. The control diet will consist of typical American foods and will be free of Brassica vegetables and free of glucosinolates and isothiocyanates. The Brassica diet will contain the control diet plus glucosinolate/isothiocyanate treatment foods. There will be a break of 3 weeks in between study periods. Blood, urine, and fecal samples will be collected at the end of each study period. Eligible participants will be selected based on genotype for glutathione S-transferase (GST), which has been shown to influence the potential protective role of dietary Brassicas. Half the participants (n=9) will be GSTM1-positive individuals and half (n=9) will have the GSTM1-null genotype.


Eligibility Criteria:
Inclusion Criteria:

* Between 21 - 70 years of age
* Not currently taking glucosinolate/ITC containing supplements
* Voluntarily agree to participate and sign an informed consent document
* Free of cancer (never diagnosed or cancer-free for at least 5 y)

Exclusion Criteria:

* Pregnant, lactating, or intend to become pregnant during the study period
* Known allergy or intolerance to Brassica vegetables
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations
* Use of tobacco products
* Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
* Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Tailoring Overdose Education for Black Churches

Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities. For Overdose Education and Naloxone Distribution (OEND) to be efficacious in Black churches, tailoring may be needed. For this audience, standard OEND curricula may need to be adapted to their level of knowledge of substance use disorders (SUDs), and limited general mental health literacy, and specifically address stigma related to SUDs and medications for opioid use disorder (MOUD). Finally, a tailored implementation strategy may need to address contextual variations (e.g., denomination and membership size) across churches. The proposed pilot study aims to identify the socio-cultural modifications that will be needed to adapt our previously developed training (i.e., COEST) to target Black communities of faith. In a pilot randomized controlled trial (RTC) of adapted COEST in a stepped-wedge design.


Eligibility Criteria:
Inclusion Criteria:

1. Identify as one of the following group members of the Black church: Clergy; Individual with OUD and/or stimulant use disorder; Family member or friend of an individual with OUD; Formerly incarcerated.
2. Age 18 and older.

Exclusion Criteria:

1. Unable to provide informed consent.
2. Less than 18 years old.
3. Does not identify as belonging to one of the four stakeholder groups.
Temporal Window and Episodic Future Thinking in CUD

The primary objective is to test the theory of Reinforcer Pathology via manipulation of the temporal window with successive Episodic Future Thinking generation in individuals with cocaine use disorder.

Adults with cocaine use disorder will be randomly assigned to experimental or control groups, stratified by polydrug use disorder, SES, and sex. The experimental group will compare episodic future thinking (EFT) to control episodic thinking (CET). The study procedures will include a baseline session (S1) and a 4-week intervention period where participants will return to the lab three times a week. Participants will generate new EFT and CET events at approximately weekly intervals. The EFT or CET events will be texted to them twice daily with urine samples obtained thrice-weekly. To probe resistance to disruption, both groups will receive stress-inducing probes that shorten the temporal window after the first and last cue generation. During the first assessment visit (S2), participants will be randomized with stratification to generate either episodic future thinking (EFT) or control episodic thinking (CET) events and will undergo neuroimaging procedures. At the following session in S3, participants will be randomized to receive one of two stress probes (counterbalanced) or their respective control. Participants will be exposed to a stress probe or control at S3 and the corresponding narrative at the next visit, S4. S5 and S6 will begin with participants generating new EFT/CET events that will be used for that session and the following two sessions. S7, like S2, will begin with EFT/CET event generation and neuroimaging procedures. During the final two sessions (S8, S9), participants will be exposed to the other stress probe and control that they did not see during S3/S4.

Eligibility Criteria:
Inclusion Criteria:

1. demonstrate recent cocaine use and CUD (use in last month, DSM-5 for CUD \> 4)
2. be 18 years of age or older
3. have a desire to quit or cut down on their cocaine use, but do not have proximate plans to enroll in treatment for CUD during the study period

Exclusion Criteria:

1. meeting moderate to severe DSM-5 criteria for opioid use disorder
2. having a current diagnosis of any psychotic disorder
3. having a history of seizure disorders or traumatic brain injury
4. having any contraindication for participation in the MRI sessions