linjc16/ctgov huggingface dataset:
Single-Dose Study of Black Cohosh and Red Clover

Study Overview
=================
Brief Summary
-----------------
This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined.

Detailed Description
-----------------
This Phase I study will assess the pharmacokinetics of two botanicals, Trifolium pratense (red clover) and Cimicifuga racemosa (black cohosh). Participants will receive a single dose of one botanical preparation. The observation period will be one week. Drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a Phase II clinical trial will be determined. The Phase II trial will examine the efficacies of red clover and black cohosh for the reduction of menopausal symptoms in healthy menopausal women. The study will be randomized, double-blinded, and placebo-controlled. Study duration will be one year.

Official Title
-----------------
A Phase I Single-Dose Pharmacokinetic Study of Black Cohosh and Red Clover in Healthy Menopausal Women 45-59 Years of Age

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: Cimicifuga racemosa
* Drug: Trifolium pratense


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy menopausal women Average body weight Able to give informed consent Exclusion Criteria: Smoker Use of any prescription medicine within the last 2 months Obesity > 30% above ideal body weight Previous history of breast or reproductive cancer Alcohol abuse or consumption above 5 glasses of wine per week or equivalent Chronic disease such as diabetes or hypertension Concurrent non-dietary phytoestrogens or hormone use; Vegans (vegetarians who tend to consume greater than average dose of phytoestrogens) Concurrent participation in other clinical trial(s) Unavailable for followup

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cimicifuga racemosa|nan|
|Drug: Trifolium pratense|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
menopause, hot flashes, botanicals
Hypnosis and MEOPA in Regional Painful Syndrome Complex

Study Overview
=================
Brief Summary
-----------------
Relation between hypnosis and MEOPA on algodystrophy.

Official Title
-----------------
Combined Therapy of Hypnosis Kinesitherapy and MEOPA in Patients With Regional Painful Syndrome Complex

Conditions
-----------------
Algodystrophy of Hand

Intervention / Treatment
-----------------
* Other: Hypnosis, kinesitherapy, MEOPA
* Other: Usual practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regional Painful Syndrome Complex Exclusion Criteria: deaf people

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis Kinesitherapy and MEOPA<br>combined therapy of Hypnosis Kinesitherapy and MEOPA (HKM) | Other: Hypnosis, kinesitherapy, MEOPA<br>* classical intervention<br>* Other names: Hypnosis Kinesitherapy and MEOPA (HKM);|
| Other: usual practice<br>physiopathology and treatments | Other: Usual practice<br>* Usual practice with treatments and physio<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measure using visual analogical ladder (EVA) | pain intensity is determined by patient himself on a visual analogical ladder created by Huskisson | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QDSA ( Saint Antoine Pain Questions) | description of the type of pain | 3 weeks | 
| SF36 (Short Form (36) Health Survey) | quality of life appreciation | 3 weeks | 
| HADs | Hospital Anxiety and Depression Scale | 3 weeks |
Assessing the Role of Exercise Intensity in Slowing Disease Progression in Early Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Participants will complete a self-selected intensity of exercising over a 6 month period, with detailed clinical assessments at commencement and completion to determine the rate of progression of parkinsonism and gait abnormalities

Detailed Description
-----------------
Participants will complete a self-selected intensity of exercising over a 6 month period - including jogging, swimming and circuit training, with detailed clinical assessments at commencement and completion (including UPDRS, gaitrite lab study) to determine the rate of progression of parkinsonism and gait abnormalities

Official Title
-----------------
Assessing the Role of Exercise Intensity in Slowing Disease Progression in Early Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early Parkinson's Disease, Able to provide informed consent, able to complete exercise diaries for 6 months, no medications or on levo-dopa Exclusion Criteria: Not on dopamine agonists,

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Intestinal Microbiome and Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Chemotherapy is commonly used as myeloablative conditioning treatment to prepare patients for haematopoietic stem cell transplantation (HSCT). Chemotherapy leads to several side effects, with gastrointestinal (GI) mucositis being one of the most frequent. Current models of GI mucositis pathophysiology are generally silent on the role of the intestinal microbiome. The aim of the study is to identify functional mechanisms by which the intestinal microbiome may play a key role in the pathophysiology of GI mucositis, the investigators applied high throughput DNA-sequencing analysis to identify microbes and microbial functions that are modulated following chemotherapy.

Official Title
-----------------
Chemotherapy-driven Dysbiosis in the Intestinal Microbiome

Conditions
-----------------
Diarrhea

Intervention / Treatment
-----------------
* Other: patients stool collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with non-Hodgkin's lymphoma Participants receiving the same myeloablative conditioning regimen for five consecutive days, including high-dose Carmustine (Bis-chloroethylnitrosourea), Etoposide, Aracytine and Melphalan. Exclusion Criteria: Patients with a history of Inflammatory Bowel Diseases (IBD), exposed to probiotics, prebiotics or broad-spectrum antibiotics, or administered nasal-tube feeding or parenteral nutrition in the month prior to initiation of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: patients stool collection|patients stool collection|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing |  | baseline | 
| analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing |  | at day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-antibiotic diarrhea, intestinal microbiome
Gatekeeper European 005

Study Overview
=================
Brief Summary
-----------------
Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo 2000-04

Official Title
-----------------
Long Term Follow-up European Gatekeeper Study 005

Conditions
-----------------
GERD

Intervention / Treatment
-----------------
* Device: Gatekeeper Reflux Repari System (Device)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have been part of the Endo 2000-03 or Endo 2000-04 clinical study Subjects who have been informed of the nature of the long-term follow-up study and have agreed to its participation and provided Informed Consent Exclusion Criteria: Underwent another endoscopic or surgical treatment for GERD (except re-intervention with Gatekeeper) Developed other medical illness that may cause the subject to be non-compliant Extensive Barrett's Esophagus (>2 cm) Unable or unwilling to cooperate with the study procedures
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Gatekeeper Reflux Repari System (Device)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Salivary Cortisol Measurements by Mass Spectrometry

Study Overview
=================
Brief Summary
-----------------
Cortisol is a hormone critical for survival in times of stress. Currently most measurements are done with blood samples. The hypothesis of this study is cortisol measured from saliva using mass spectrometry can be used to replace measurements by blood.

Detailed Description
-----------------
Cortisol levels change depending on the time of day. Salivary samples were collected from health controls at bedtime, midnight and first morning waking on two consecutive nights and salivary cortisol levels were measured using mass spectrometry. In a patients with possible endocrine disorders who were going through an adrenocortiotropin stimulation test for adrenal insufficiency, salivary cortisol was measured prior to giving cosyntropin and 30-40 minutes after cosyntropin.

Official Title
-----------------
Pilot Study of Salivary Cortisol Measurements by Mass Spectrometry

Conditions
-----------------
Endocrine Disorders

Intervention / Treatment
-----------------
* Other: Non intervention study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal subjects Subjects with possible endocrine disorder Exclusion Criteria: Tracheostomy or ventilator dependent Gastrotomy tubed dependent or unable to eat/drink by mouth

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non intervention study|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary Cortisol |  | All collections are done within 48 hours |
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to investigate in a randomised double-blind trial whether treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less.

Official Title
-----------------
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Drug: Sildenafil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborn babies born <28 weeks of gestation who still need ventilatory support via endotracheal tube or have been re-ventilated at day 7 of life. Exclusion Criteria: Congenital heart defects Suspected inborn error of metabolism Inhaled Nitric Oxide treatment during assessment

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Sildenafil oral solution. | Drug: Sildenafil<br>* Sildenafil oral solution<br>* Other names: Revatio(R);|
| Placebo Comparator: 2<br>Placebo oral solution. | Drug: Placebo<br>* Placebo solution<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ventilation |  | 12 months after completion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchopulmonary Dysplasia (BPD) |  | 12 months after completion of study |
Predicting Infant Extubation Using Diaphragm Surface Electromyography

Study Overview
=================
Brief Summary
-----------------
This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

Detailed Description
-----------------
This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

Official Title
-----------------
Predicting Infant Extubation Using Diaphragm Surface Electromyography

Conditions
-----------------
Infant, Newborn, Disease

Intervention / Treatment
-----------------
* Device: Recording of diaphragm EMG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intubated and mechanically ventilated on NICU Exclusion Criteria: major congenital abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intubated infants<br>Recording of diaphragm EMG | Device: Recording of diaphragm EMG<br>* Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude of diaphragm EMG | Magnitude of diaphragm EMG | One hour | 
| Ratio of diaphragm EMG to tidal volume | Ratio of diaphragm EMG to tidal volume | One hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation success | Extubation success is define as remaining free of invasive mechanical ventilation. Whether the above measures of diaphragm EMG can predict such success will be investigated | 48 hours |
Dermacyd Breeze (Lactic Acid) Pocket BR - Compatibility

Study Overview
=================
Brief Summary
-----------------
To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Breeze (Lactic Acid) Pocket BR.

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Breeze Pocket BR.

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age between 18 and 60 years old; Phototype Skin I,II, III e IV Integral skin test in the region; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; Exclusion criteria: Lactation or gestation Use of Antiinflammatory and/or immunosuppression drugs one month before the study; Personal history of atopy; History of sensitivity or irritation for topic products; Active cutaneous disease; Use of new drugs or cosmetics during the study; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lactic Acid (Dermacyd Breeze) | Drug: Lactic Acid<br>* Lactic Acid (Dermacyd Breeze)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. |  | Throughout the study |
Chronic Pain Dynamic Psychophysical Tests and Genetic Screening

Study Overview
=================
Brief Summary
-----------------
Incidence and risk factors for persistent post surgical pain after Caesarean section are investigated. Demographic, psychophysical testing and genetic screening factors are performed in the perioperative period. Phone survey is performed to investigate the incidence of persistent post surgical pain after Caesarean section.

Detailed Description
-----------------
Persistent post surgical pain after Caesarean section may lead to functional limitation and pain during activities of daily living. Demographic factors, psychophysical factors (mechanical temporal summation, diffuse noxious inhibitory control, state trait anxiety inventory) and genetic screening are used to predict the association with persistent post surgical pain. Phone survey follow up is performed to investigate the incidence of persistent post surgical pain and functional limitations due to pain experienced.

Official Title
-----------------
Prediction of Chronic Pain in the Asian Population- Comprehensive Programme Encompassing Dynamic Psychophysical Tests and Genetic Screening to Determine and Prevent Persistent Post-caesarean Pain

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing spinal anaesthesia for Caesarean section Exclusion Criteria: Failed spinal anaesthesia, Unable to perform psychophysical testing.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent Postsurgical Pain | Pain experienced in the lower abdominal region and surgical area after Caesarean section | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caesarean section, Pain